03 MAR 2022 Russia/Ukraine conflict business continuity statement:
Associates of Cape Cod, Inc. (ACC) confirms that the Russia/Ukraine conflict currently has no impact on ACC product manufacturing or service provision, and ACC does not source raw materials or critical items from that geographical region.

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Careers

LAL Production Technician

Seeking hardworking, motivated and reliable people for positions in our Manufacturing team. Experience not necessary, we provide the training. Good attitude a must. With direct supervision this individual will perform routine manufacturing operations for the manufacture of ACC and SKK commercial products. Individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), and applicable records. The individual will complete required training on time, demonstrate acceptable attendance as well as respect for coworkers.

General Responsibilities:

  • Can work in a team atmosphere and with minimal supervision
  • Possess a positive attitude and desire to learn
  • Work on their feet in a fast-paced environment
  • Read and write English
  • Lift up to 50 lbs.
  • Have restaurant, manufacturing experience, or simply want to learn something new
  • Fill and finish technicians
  • Formulation of finished product
  • Filling operations
  • Cleaning of controlled process areas
  • Glassware preparation
  • Cleaning of controlled process areas
  • Machine operation (crimping/filling/ Freeze dryer operation)

Knowledge and Skill Requirements:

  • Experience in manufacturing is desirable
  • Must be able to get along with and respect others
  • Be able to lift at least 25 lbs.
  • Basic computer skills needed

Education and Experience:

  • A minimum of a High School diploma or equivalent and 0-2 years related industry experience
  • Associates degree or equivalent is an advantage

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for LAL Production Technician here.

In your cover letter please answer the following:

  • Have you completed the following level of education: High School diploma and 0-2 years related industry experience?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Quality Assurance Manager

Purpose: Management of quality systems and associated activities to ensure the Quality Management System is compliant to ISO 13485, 21 CFR 820, other applicable regulations, and internal procedures.

General Responsibilities:

  • Maintain and support ACC's quality management system to ensure it meets 21 CFR Part 820, ISO 13485, other applicable regulations and customer expectations
  • Oversight of all Quality Systems, including change control, complaints, CAPA etc.
  • Support quality record review as the quality assurance representative or designee for the Director of Quality where indicated
  • Manage the Annual Product Review process
  • Support all audit activities, internal, supplier, customer, regulatory Perform training on quality systems and quality-related issues
  • Support generation of Compliance metrics
  • Update procedures as needed
  • Other major projects and duties as assigned

Knowledge and Skill Requirements:

  • 5+ years experience in an ISO/FDA regulated industry, biologics experience preferred
  • 2+ years of management experience
  • Working knowledge of ISO 9001, ISO 13485 and 21 CFR Part 820 regulations
  • High attention to detail, excellent organizational, written and oral communication skills, the ability to work with others and independently in a fast-paced environment, possess a high degree of critical thinking skills, and at least intermediate level user of MS Office applications

Education and Experience:

  • A minimum of a Bachelor's degree in life science or an equivalent combination of experience and/or education required
  • 5+ years of experience in biotech or pharmaceutical industry is preferred

General Competencies:

  • Uses resources efficiently, strives to reduce cost, part of the budgeting process
  • Communicates well (written and verbal), delivers presentations, has good listening skills
  • Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets, and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Works well with internal and external customers, promotes a positive image of the company, and strives to solve issues raised by customers
  • Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Honest, accountable, maintains confidentiality
  • Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
  • Takes action, seeks new opportunities, and strives to see projects to completion within the boundaries of the job description
  • Creative, offers new ideas, risk taker, amenable to change
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Provides strong leadership, sets a good example, skilled decision maker, motivator, encourager
  • Information organized and accessible, maintains efficient work space, manages time well
  • Strives to understand contributing factors, works to resolve complex situations
  • Manages workload, works efficiently, meets goals and objectives
  • Monitors status of projects, thoroughly deals with project details, holds project owners accountable, and delivers clear, accurate depiction of status
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
  • Defines appropriate goals, works toward achieving goals, articulates vision and steps for achievement
  • Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
  • Accountable to team, works to meet established deliverables, appreciates view of team members, respectful
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

  • Frequently sit and stand. Occasionally walk, use hands to finger, handle or feel. Occasionally reach with hands or arms, climb or balance, stoop, kneel, crouch or crawl. Constantly talk or listen, occasionally taste or smell. Frequently work near moving mechanical parts; occasionally work in high places, occasionally exposed to fumes or airborne particles. Occasionally exposed to toxic or caustic chemicals.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Quality Assurance Manager here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Document Control Associate

Purpose: Maintain Document Control systems and activities in compliance with ACC policies and procedures, QSRs and 13485.

General Responsibilities:

  • Document Runner: transport and deliver documents/records to and from designated points for Document Control
  • Maintain Document Control databases and logs such that they are up to date, efficient, and accurate at all times
  • Maintain and control archive storage locations such that they are kept up to date and organized for ease of retrieval of records, and in a manner that prevents damage and misuse
  • Data entry
  • Scan/file/log records for archival, including training records
  • Retrieve archived records upon request and maintain archive activity log
  • Enter lot information into the Labeling databases per procedures
  • Participate in the process for preparing records for offsite storage and retrieval of those records when needed
  • Participate in the process for Record Retention and shredding
  • Participate in preparing documents for use in a timely manner such as Production binders (PHR’s), in-process paperwork, kitting and packaging requests, etc
  • Participate in quarterly review activities for Level 0 Documents (regulatory standards, guidance’s, etc)
  • Scan and upload certificates of analysis and certificates of compliance for Customer Service and website
  • Complete all QMS and training activities in a timely manner
  • Support and prioritize all Document Control related activities and requests for records
  • Prepare for, support, and participate in customer, regulatory, and internal audits
  • Other duties as assigned

Knowledge and Skill Requirements:

  • Working knowledge of cGMP, ISO 13485 and principles of document control
  • Detail oriented and excellent organizational skills
  • Ability to work in a fast paced team environment
  • Ability to work on multiple tasks and meet deadlines
  • Excellent oral and written communication skills
  • Proficiency in all office based software

Education and Experience:

  • A minimum of an Associates Degree or equivalent combination of experience and/or education required
  • Minimum of 1 years experience working in an FDA and/or ISO regulated environment or equivalent combination of experience and/or education required

General Competencies:

  • Communicates well (written and verbal), delivers presentations, has good listening skills
  • Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Works well with internal and external customers, promotes a positive image of the company, and strives to solve issues raised by customers
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Honest, accountable, maintains confidentiality
  • Information, organized and accessible, maintains efficient work space, manages time well
  • Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks
  • Manages workload, works efficiently, and meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements

Physical Requirements:

  • Constantly sit, occasionally stand, frequently walk, occasionally use hands to finger, handle, or feel. Constantly reach with hands or arms, climb or balance, stoop or kneel, crouch or crawl. Constantly talk or listen. Lift 11-25 lbs 1-33% of the time. Carry 11-25lbs 1-33% of the time. Occasionally exposed to toxic or caustic chemicals. The work environment is typically quiet for this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Document Control Associate here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Associates Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Temporary Glass Washer - Flexible Schedule

Purpose: Seeking hardworking, motivated and reliable people for positions in our Manufacturing team. Experience not necessary, we provide the training. Good attitude a must. Seeking temporary workers to assist with the preparation of glassware for sterilization. Applicants must be hard working, careful, team players with a positive attitude. Work will last from August until approximately December. Perfect for students or others seeking experience in the biotech field. Must be 18+ to be considered. Responsible for all functions related to glass washing/sanitation. Flexible schedules available to include full-time, part-time or mother's hours.

General Responsibilities:

  • Assisting with preparation glassware for sterilization
  • Washing drying and wrapping of glassware
  • Handwashing / operation of commercial washer
  • Mopping / cleaning of glass wash room
  • Full time / part time/ mothers hours available

Knowledge and Skill Requirements:

  • Can work in a team atmosphere and with minimal supervision
  • Possess a positive attitude and desire to learn
  • Work on their feet in a fast-paced environment
  • Read and write English
  • Lift up to 50lbs
  • Have restaurant, manufacturing experience, or simply want to learn something new

Job Type: Full-Time and/or Part-Time

To Apply:

Please submit a current resume and cover letter for Temporary Glass Washer here.

In your cover letter please answer the following:

  • Have you completed the following level of education: High School Graduate?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Temporary Laboratory Technician - Flexible Schedule

Purpose: Seeking hardworking, motivated and reliable people for positions in our Manufacturing team. Experience not necessary, we provide the training. Good attitude a must. Seeking temporary workers to collect and process blood cells from horseshoe crabs to make LAL - a test for a bacterial toxin. Applicants must be hard working, careful, team players with a positive attitude. Work will last from August until approximately December. Perfect for students or others seeking experience in the biotech field. Must be 18+ to be considered. Responsible for all functions related to Horseshoe Crab bleeding, and processing. Flexible schedules available to include full-time, part-time or mother's hours.

General Responsibilities:

  • Receiving crabs and unloading barrels of crabs from trucks
  • Bleeding crabs, initial cell processing, and operation of centrifuges
  • Washing and preparing all bleed related glassware
  • Cleaning of labs
  • Cleaning of controlled process areas
  • Other duties as assigned by supervisor
  • 8-9 hour days 3-5 days a week FT preferred

Knowledge and Skill Requirements:

  • Can work in a team atmosphere and with minimal supervision
  • Possess a positive attitude and desire to learn
  • Work on their feet in a fast-paced environment
  • Read and write English
  • Lift up to 50lbs
  • Have restaurant, manufacturing experience, or simply want to learn something new

Job Type: Seasonal - Full-Time or Part-Time

To Apply:

Please submit a current resume and cover letter for Temporary Laboratory Technician here.

In your cover letter please answer the following:

  • Have you completed the following level of education: High School Graduate?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Facilities Supervisor

In this role, you will supervise the day-to-day operations of the maintenance group which includes planned maintenance activities and unplanned repairs of the facility and its equipment.

General Responsibilities:

  • Provide excellent support to the various groups within the building
  • Support the facilities maintenance team by providing leadership and technical, resource and planning assistance
  • Maintain a working knowledge of the team’s workload to efficiently delegate unscheduled work requests
  • Confirm scheduled and unscheduled work is completed by their due dates
  • Complete reviews of all maintenance work in a timely manner
  • Prioritize work while considering the maintenance team’s activities as well as the needs of the groups we support
  • Provide open lines of communication with groups we support
  • Oversee onsite contractors
  • Must be available for on-call for emergencies

Education and Experience:

  • A Bachelor's Degree in a scientific or engineering field or an equivalent combination of experience and/or education is required
  • A minimum of five years’ experience troubleshooting, repairing, and maintaining typical building systems such as steam, electrical, plumbing, pneumatic and HVAC systems preferably in cGMP manufacturing facility or other highly regulated industry. Building automation experience is a plus
  • A minimum of three years’ experience in a leadership/supervisory role
  • Previous experience in cGMP or another highly regulated industries where exceptional organizational and documentation skills, accuracy and attention to detail are paramount to the success of the company
  • Proficient with computerized maintenance management systems. Blue Mountain RAM a plus

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Facilities Supervisor here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's Degree in a scientific or engineering or equivalent?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Sr. Software Engineer

Design and develop software to support the manufacture, sale and support of ACC’s endotoxin and glucan detection products and develop/maintain software to support company’s line of business.

General Responsibilities:

  • Analyze User Needs and develop high-quality, innovative software with operational efficiency.
  • Work closely with BAs, SMEs and Software Developers to develop software requirements specification and software design specifications
  • Design and implement software for Bio/medical devices and systems from requirements to production and commercial deployment
  • Responsible for design, debug, and integration of software C#/Java applications running in a MS Windows environment
  • Give aid and guidance to junior engineering staff.
  • Lead and direct activities on development  project
  • Contribute to the improvement of the development life cycle.
  • Be self-empowered, take ownership of, and responsibility for your work
  • Collaborate and communicate effectively with team members and with other teams
  • Work independently and know when to ask for help
  • Perform comprehensive unit and integration testing of all software produced
  • Participate in group design and code reviews
  • Review code and work with software quality assurance to ensure that all software meets company or medical device standards
  • Stay abreast of the latest technology and industry best practices
  • Understand the software development life cycle

Knowledge and Skill Requirements:

  • Must demonstrate significant proficiency in C#/Java
  • Documents and demonstrates solutions by developing documentation, flowcharts, layouts, diagrams, code comments and clear code. 
  • Ability to gather and understand User Needs/Requirements
  • Ability to work in a very fast paced environment
  • Familiarity with software configuration management tools, defect tracking tools, and peer review
  • Familiarity with relational databases
  • Any exposure or knowledge of the Bio/Medical industry is a strong plus

Nice To Have:

  • Experience implementing software for class I or II medical devices
  • Object-oriented design and development, and C#, are strongly preferred
  • Experience with Visual Studio, Git, Helix ALM and Microsoft Team Foundation Server
  • Experience with IEC-62304, ISO-13485, and ISO-14971

Education and Experience:

  • Bachelor’s Degree in Biomedical Engineering, Software Engineering, Computer Science, Applied Mathematics, Electrical Engineering or a related field or equivalent combination of education and experience.
  • 8 or more years of software development using C#/Java
  • Good written and oral communications skills, strong attention to detail and willingness to follow directions and established procedures with minimal supervision. 

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Sr. Software Engineer here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's or equivalent?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Senior Quality Assurance Specialist

Purpose: Assures compliance to ACC policies and procedures and applicable external standards for product development, quality control, and manufacturing. Manages audit processes for internal, customer, supplier, regulatory and mail audits. Manages Quality Assurance process for supplier approval. Provides recommendations to teams as they work within the different Quality System Elements, such as Design Control and investigation activities within all Quality Systems.

General Responsibilities:

  • Manage the audit program, internal, supplier, customer, regulatory and mail audits, including coordination of scheduling, hosting, participation and management of findings
  • Provide support, leadership and guidance on the Quality System, specifically as it pertains to Quality System Regulations and per defined procedures
  • Manage data collection and Annual Product Review process
  • Contribute to Compliance quarterly metrics generation
  • Support ProcessCompliance activities in eQMS
  • Review Change Control activities
  • Review standards and guidances for compliance as needed
  • Support product development and other teams in risk management and design control activities
  • Lead and/or participate in cross-functional project teams to support new product development, design changes, computer system implementation, and quality system improvements
  • Provide support for all quality-related investigations, including acting as facilitator of investigation teams and conduct of investigations, as needed
  • Review of quality management system documentation and records as the Quality Assurance representative
  • Participate in supplier qualification and monitoring processes including supplier approval
  • Support and participate in FDA and Notified Body Audits
  • Coordinate and facilitate Quality Management Reviews, and ensure that metric reporting requirements are met
  • Other major projects and duties as assigned

Knowledge and Skill Requirements:

  • 5+ years of experience in an ISO/FDA regulated industry
  • Risk management experience including generating risk analysis and applying the concepts and principles of ISO 14971
  • Project Management and Design Control experience preferred
  • Knowledge of FDA GMPs, ISO 13485 and applicable regulations
  • Experience in auditing techniques including developing audit plans, scheduling and audit report generation
  • Experience with investigation activities and root cause analysis

Education and Experience:

  • A minimum of a Bachelor degree in science-related field or an equivalent combination of experience and education required.

General Competencies:

  • Adapts to change, open to new ideas and responsibilities
  • Communicates well (written and verbal), delivers presentations, has good listening skills
  • Performs tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Works well with internal and external customers, promotes a positive image of the company, and strives to solve issues raised by customers
  • Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Honest, accountable, maintains confidentiality
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Information organized and accessible, maintains efficient work space, manages time well
  • Strives to understand contributing factors, works to resolve complex situations
  • Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer choices
  • Manages workload, works efficiently, and meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
  • Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

Constantly sit, occasionally stand, and frequently walk. Occasionally use hands to finger, handle or feel. Occasionally reach with hands or arms, occasionally climb or balance, stoop, kneel, crouch or crawl. Constantly talk. Lift 11 to 25 lbs, 1-33% of the time. Carry 11 to 25 lbs, 1-33% of the time.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Senior Quality Assurance Specialist here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Customer Service Representative

Purpose: The Customer Service Representative (CSR) is responsible for interacting with customers via the phone to process orders for products and services for worldwide distribution. This position requires excellent interpersonal and communication skills, a command of the ACC ordering system and an in depth knowledge of the products and their uses. The CSR needs to be comfortable with speaking with customers to build rapport, and be able to resolve minor disputes amiably so as to retain the customer’s loyalty to ACC.

General Responsibilities:

  • Process customer orders via fax, phone and email
  • Provide inventory alerts to manufacturing
  • Support sales by providing literature, forwarding sales leads, coordinating technical support
  • Perform workshop registration
  • Invoicing for all services and billing for orders
  • Process orders
  • Maintain and Manager customer database and files
  • Issue return authorizations
  • Initiate complaint forms

Knowledge and Skill Requirements:

  • Data entry skills
  • Excellent verbal communication skills
  • Self starter, highly motivated with the ability to multi task in a fast paced environment
  • Willing to learn new technologies
  • Microsoft Excel, Word
  • Knowledge of ACC products

Education and Experience:

  • Must have 3-5 years Customer Service experience preferably in a GMP/ISO product environment
  • Must have a minimum of a High School diploma or equivalent

General Competencies:

  • Communicates well (written and verbal), delivers presentations, has good listening skills
  • Performs tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (power point). The level of proficiency is defined by the requirements of the position held
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Works well with internal and external customers, promotes a positive image of the company, strives to solve issues raised by customers
  • Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Honest, accountable, maintains confidentiality
  • Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
  • Takes action, seeks new opportunities, strives to see projects to completion within the boundaries of the job description
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Information organized and accessible, maintains efficient work space, manages time well
  • Manages workload, works efficiently, and meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
  • Meets deadlines, establishes appropriate priority, gets the job done in a timely manner
  • Accountable to team, works to meet established deliverables, appreciates view of team members, respectful

Physical Requirements:

Constantly sit, frequently stand and walk. Constantly use hands to finger, handle, or feel. Constantly reach with hands or arms. Occcasionally stoop, kneel, crouch, or crawl. Constantly talk or hear. Lift 1-10 lbs 1-33% of the time. Carry 1-10 lbs, 1-33% of the time. Work environment for this job is very quiet.

Job Type: Full-Time and/or Part-Time

To Apply:

Please submit a current resume and cover letter for Customer Service Representative here.

In your cover letter please answer the following:

  • Have you completed the following level of education: High School Diploma?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Purchasing Agent

Purpose: Responsible for all phases of the procurement process within ACC's established procedures. This would include assurance of the supply of critical raw materials and operating supplies, effective negotiation of contracts for services, development of a reliable supplier base and ensure policies and procedures are compliant with existing quality standards. Provide a high quality of service and ethics. Maintain and monitor Supplier Qualifications.

General Responsibilities:

  • Plan & release purchase orders in support of the Production Plan. This would include raw materials, operation supplies and critical services
  • Generate / maintain detailed reports of purchasing requirements and purchase material status
  • Supply product availability information to Customer Service for purchased finished goods
  • Assist R&D, Quality, Engineering and Marketing to source new materials and suppliers. Negotiate favorable terms and price reductions while maintaining ACC quality objectives
  • Ensure the purchasing function maintains compliance to all appropriate quality systems (ISO 13485 and FDA)
  • Develop and update SOP's to support the purchasing function

Knowledge and Skill Requirements:

  • Excellent skills using MS Word & Excel
  • Knowledge of ERP planning systems and detailed MRP purchasing experience
  • Knowledge of the supply chain process and strong negotiation skills
  • Ability to source new materials and manage the competitive quote process
  • Ability to build effective relationships with internal customers and ACC supplier base
  • Effective working in a team environment

Education and Experience:

  • A minimum of a BS in a business discipline or equivalent combination of experience and/or education required
  • 5 years technical purchasing experience, preferably in a medical device or pharmaceutical environment
  • APICS or C.P.M. certification preferred
  • Experience with cGMP and ISO-9001 or 13485 quality systems are preferred

General Competencies:

  • Adapts to change, open to new ideas and responsibilities
  • Communicates well (written and verbal), delivers presentations, has good listening skills
  • Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
  • Honest, accountable, maintains confidentiality
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Strives to understand contributing factors, works to resolve complex situations

Physical Requirements:

Constantly sit, occasionally stand, walk, constantly use hands to finger, handle or feel. Position might require some business travel - Smaller 5%.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Purchasing Agent here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor’s Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Production Floor Supervisor

Purpose: To supervise the manufacturing of ACC products per approved procedures and an established schedule.

General Responsibilities:

  • Oversee day to day operations on the manufacturing floor
  • Assist with the manufacturing of ACC products per approved SOPs
  • Verify that proper documentation is generated to support the produced product
  • Interface with multiple departments i.e., materials and quality to assure that the production schedule can be achieved in an effective manner
  • Participate in and lead teams toward improved manufacturing performance
  • Provide training to newly hired personnel
  • Participate in QE and OOS investigations
  • Draft daily department schedule
  • Other tasks as requested

Knowledge and Skill Requirements:

  • Knowledge of GMP manufacturing processes preferred
  • Above average communication skills
  • Manufacturing experience
  • MS word and excel capability
  • Experience working in a ISO certified industry preferred

Education and Experience:

  • A minimum of a high school diploma or equivalent or a combination of experience and education required
  • AS or BS in a science related field preferred
  • 3-5 yrs experience supervising in a GMP/ISO manufacturing environment

General Competencies:

  • Adapts to change, open to new ideas and responsibilities
  • Uses resources efficiently, strives to reduce cost, is part of the budgeting process
  • Communicates well (written and verbal), delivers presentations
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Works well with internal and external customers, promotes a positive image of the company, strives to solve issues raised by customers
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Provides strong leadership, sets a good example, skilled decision maker, motivator, encourager
  • Information organized and accessible, maintains efficient work space, manages time well
  • Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient workflow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer choices
  • Manages workload, works efficiently, meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
  • Monitors and promotes safe practices on the manufacturing floor
  • Defines appropriate goals, works toward achieving goals, articulates vision and steps for achievement
  • Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
  • Accountable to team, works to meet established deliverables, appreciates view of team members, respectful

Physical Requirements:

Frequently sit and stand. Occasionally use hands to finger, handle or feel. Occasionally reach with hands or arms, climb or balance. ccasionally stoop, kneel, crouch, or crawl. Constantly talk or listen. Occasionally taste or smell. Lift 1-10 lbs 1-33% of the time. Carry 1-20 lbs, 1-33% of the time. Frequently work near moving parts; occasionally work in high places, occasionally exposed to fumes or airborne particles. Occasionally exposed to toxic or caustic chemicals. Moderate noise is typical for this work environment of this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Production Floor Supervisor here.

In your cover letter please answer the following:

  • Have you completed the following level of education: High School Diploma?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Lead Production Technician

Purpose: With minimal supervision this individual will deliver leadership and excellence in manufacturing ACC and SKK Products. The incumbent assists Management with scheduling to meet site demands and observes floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. Provide interactions with support groups / departments to ensure accurate communication and continuous flow of manufacturing processes. Provide support to integrate best practices, whereappropriate, into manufacturing.

General Responsibilities:

  • Primary contact for troubleshooting and issue resolution or escalation
  • Create and follow up on work orders
  • Communicate/coordinate days scheduling and staffing plan
  • Re-allocate staff as needed during the day (breaks, lunch, training, etc.)
  • Oversight and execution of all routine and critical operations as well as commissioning and validation activities
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
  • Ensure documentation is complete, verified, and meets good documentation practices
  • Responsible for floor inventory and communicating deficiencies
  • Recommend/implement process changes/improvements or safety/ergonomic improvements
  • Ensure work is carried out in a safe manner, notifying management of safety issues and risks
  • Address minor personnel issues timely
  • Escalate major personnel issues to the supervisor
  • Act as a resource/subject matter expert (SME) for staff
  • Conduct training and assess effectiveness
  • Assess staff skill sets and provide feedback to supervisor
  • Must be able to work overtime as required
  • Must be able to work weekends as required
  • Other duties as assigned by supervisory staff

Knowledge and Skill Requirements:

  • Experience in manufacturing is desirable
  • Must be able to get along with and respect others
  • Be able to lift at least 25 lbs.
  • Computer skills are necessary in this function
  • Act as a role model (lead by example)

Education and Experience:

  • Associates degree and 1-4 years related experience or 4-6 years industry experience or an equivalent combination of experience and/or education required
  • Bachelors of Science degree or equivalent is an advantage with 2-4 years of GMP Manufacturing experience
  • Mastery of requirements of Production Tech III job function

General Competencies:

  • Adapts to change, open to new ideas and responsibilities
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Honest, accountable, maintains confidentiality
  • Manages workload, works efficiently, meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
  • Accountable to team, works to meet established deliverables, appreciates view of team members, respectful, works effectively with Management

Physical Requirements:

  • Occasionally sit, constantly stand, and constantly walk. Frequently use hands to finger, handle, or feel. Constantly reach with hands or arms, occasionally climb or balance. Constantly talk or listen. Frequently exposed to toxic or caustic chemicals. Occasionally exposed to extreme cold (non-weather), occasionally exposed to extreme heat (non-weather)
  • Occasionally exposed to uneven surface, and occasionally exposed to vibration. Moderate noise is typical for the work environment of this job

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Lead Production Technician here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Associates Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Quality Assurance Specialist

Purpose: Ensure that the Quality Management System is compliant to ISO 13485, 21 CFR 820, other applicable standards/regulations and internal procedures.

General Responsibilities:

  • Review and release of batch history paperwork prior to product release to ensure all requirements are met within the required timeframe to support ACC business needs
  • Review and release of kit requisitions
  • Investigate, coordinate, and resolve Quality System Events in a timely manner as needed
  • Participate in maintaining quality system databases and processes
  • Responsible for generating metrics reports for trending and reporting mistake free paperwork for all departments
  • Participate in Quality Improvement Teams as a representative of the Quality Assurance department
  • Write, revise, and train on Standard Operating Procedures
  • Perform CAPA and audit finding related activities as needed, including effectivity checks and follow up
  • Quality Assurance review of quality records, reports, and data (Contract Test Service reports, Quality Control data, instrument calibration reports, certificates, etc.)
  • Quality Assurance review of other quality records
  • Performing receipt and release activities as needed (includes inspection and/or release of materials, including instruments, in the ERP system)
  • Support QA inspection team as needed
  • Participate in year-end inventory activities, as needed
  • Conduct Quality Records Practices training for employees as required
  • Perform internal quality system audits, or support the process, as needed
  • Perform Supplier quality system audits, or support the process, as needed
  • Complete Supplier Quality questionnaires
  • Provide support for and/or lead on-site customer audits, including the processing of audit findings and follow up
  • Participate in or support FDA and ISO audits as required
  • Other projects and duties as assigned

Knowledge and Skill Requirements:

  • Strong working knowledge of 21 CFR 820, GMP, ISO 13485
  • Detail oriented and excellent organizational skills
  • Ability to work in fast paced team environment
  • Ability to work on multiple tasks and meet deadlines
  • Excellent oral and written communication skills
  • Proficiency in all office based software
  • Use of Microsoft Excel (graphing techniques) and Word (formatting, spelling, creating tables). Excellent computer skills

Education and Experience:

  • A minimum of a Bachelor's degree or an equivalent combination of experience and/or education required
  • A minimum of 2 years' experience in an FDA regulated industry, biotech or other related industry or equivalent experience
  • Experience with audits preferable

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Quality Assurance Specialist here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Logistics Technician 1

Description: Work as part of a team where needed in one of the 4 Logistics Departments. To include controlling of inventory in the Finished goods and Raw and WIP material warehouses, receiving incoming packages/shipments, labeling of product, packaging final product for sale, and fulfillment of customers’ orders.

This position will be primarily working in our Packaging department but may be called upon to work in Shipping, Receiving or our Labeling departments

This is fulltime entry level position, experience is a plus but not required, will train the right candidate.

General Responsibilities:

  • Shipping;
  • Fulfillment of all Customers orders
  • Preparation of all outgoing shipments including documentation for those shipments
  • Control of all “Finished Released” product
  • Receiving;
  • Receives/stores all materials for ACC use
  • Performs all necessary receiving transaction within Data Management System (DMS). Confirms accuracy of receipt against ACC documentation/Purchase Order
  • Receipt of Testing Services samples
  • Fulfills and completes transactions of all raw material in-house material requisitions
  • Control of all RAW inventory
  • Kitting/packaging;
  • Assists Kitting Department as needed, in the manufacturing/packaging of finished product to be sold to customers
  • All necessary DMS transactions for the above packaging process
  • Control of all WIP material
  • Labeling;
  • Assists in the labeling department as needed, labeling finished products as well as in-process material
  • Control of all Label WIP material
  • Additional;
  • In addition to the above tasks, assisting in weekly cycle counts in all areas
  • Absentee coverage in all areas

Knowledge and Skill Requirements:

  • Detail oriented
  • Strong organizational skills
  • Good communications skills
  • Working computer knowledge
  • Ability to multitask

Education and Experience:

  • High school diploma or equivalent
  • Detail oriented
  • Strong organizational skills
  • Good communications skills
  • Working computer knowledge
  • IATA/DOT knowledge a plus

General Competencies:

  • Able to work independently or as part of a team within a fast paced fast-paced deadline environment
  • Ability to multitask
  • Ability to be flexible and shift direction easily
  • Ability to prioritize
  • Ability to read and follow direction

Physical Requirements:

  • Ability to lift at least 25 lbs.
  • Ability to do repetitive jobs/movements
  • Ability to work on your feet for extended periods of time

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Logistics Technician 1 here.

In your cover letter please answer the following:

  • Have you completed the following level of education: High school diploma or equivalent?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

CTS  Analyst

Purpose: Perform BET and/or method development/validation on samples received in CTS based on USP <85>/<161> standards, cGMP, and ACC standard operating procedures (SOP).

General Responsibilities:

  • Perform testing using each of the three LAL methods (gel clot, turbidimetric, and chromogenic) as per SOP's
  • Interpret results from LAL test methods
  • Be familiar with the quality policy for ACC
  • Be familiar and follow the ACC safety policy
  • Be familiar with and follow the standard operating procedures (SOP) for ACC
  • Report results to clients following cGMP standards and ACC SOP's
  • Interact with clients to determine their testing needs
  • Interact with clients when their samples present problems
  • Interact with clients when a sample needs to be retested
  • Proper documentation of interactions with clients
  • Check standardization of CSE for gel clot, turbidimetric, and chromogenic methods
  • Write, revise, and review CTS standard operating procedures (SOP)
  • Utilize calibrated/certified equipment and instrumentation – notify responsible departments if equipment/instrumentation is out of calibration/certification
  • Maintain certification in all three LAL methods
  • Identify samples for disposal and follow correct/appropriate disposal procedure
  • Prepare glassware for laboratory use
  • Use appropriate procedures for laboratory and biohazard waste
  • Attend training as scheduled by ACC
  • Other duties as assigned

Knowledge and Skill Requirements:

  • Strong organizational skills
  • Must be detail oriented and have good aseptic/laboratory technique
  • Ability to work independently, as well as, with others in a fast paced laboratory environment
  • Excellent oral and written communication skills
  • Working knowledge of cGMP, ISO 9001, ISO 13485, and internal standard operating procedures and policies
  • Required to pass a pipetting proficiency training and certification course
  • Other – Hepatitis B vaccination

Education and Experience:

  • Bachelor's Degree in Chemistry, Biochemistry, or a related scientific discipline.

Physical Requirements:

Constantly sit, occasionally stand and walk. Constant use of hands to finger, handle or feel. Frequently reach with hands or arms, constantly talk or listen. Lift 1-10 lbs 1-33% of the time. Carry 1-10 lbs 1-33% of the time. Frequent exposure to fumes or airborne particles, toxic or caustic chemicals, also frequent exposure to vibration. Moderate noise is typical for the work environment of this job.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for CTS Analyst here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor’s Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Manufacturing Administrative Assistant

Purpose: Performs administrative duties and tasks to support the Production and LAL Manufacturing processes, working within ACC standard operating procedures (SOP).

General Responsibilities:

  • Review and approve documentation associated with various manufacturing processes. Including but not limited to: LAL Manufacturing documentation for filtration, homogenization, and creation of various LAL part numbers used in the manufacture of ACC products
  • Review all logbooks used during the manufacturing processes
  • Manufacturing Department meeting management (agenda's, minutes, action items, etc.) as required
  • Convert technician job notes into SOP's
  • Manage minor document changes within QUMAS
  • Manage minor QE's and deviations within QUMAS
  • Manage minor OOT investigations
  • Submit/route purchase requisitions
  • Review training in QUMAS for full time staff and ensure compliance
  • Maintain training records for LAL Manufacturing Temporary staff during the bleed months
  • Adjust inventory levels within the eDMS, track completed lots
  • Data backup for lyophilization process
  • Collect depyrogenation charts and ensure logbook compliance
  • Data retrieval in support of investigations
  • Order materials and sub-assemblies in support of Production operations
  • All other duties as assigned

Knowledge and Skill Requirements:

  • Computer skills (MS Word, MS Excel, Adobe Acrobat, Great Plains, QUMAS)
  • Ability to manage multiple tasks in a timely manner, work independently, meet deadlines
  • Flexibility and the ability to juggle priorities
  • Excellent communication, organizational and interpersonal skills
  • Must be able to take initiative with activities
  • Highly organized self-starter with ability to work well with others
  • Ability to learn new functions and operation systems within the Manufacturing process

Education and Experience:

  • One to three years of administrative experience preferred
  • Prior experience with proven ability to demonstrate interpersonal, written, verbal and organizational skills
  • A minimum of an associate degree or an equivalent combination of experience and/or education required

General Responsibilities:

  • Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
  • Works well with all ACC personnel and promotes a positive image of the Manufacturing department and strives to resolve issues working well with other departments
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Information organized and accessible

Physical Requirements:
Constantly sitting, occasionally standing and walking. Constantly uses hands to finger, handle or feel. Frequently reach with hands or arms, occasionally climb or balance, stoop, kneel, crouch, or crawl. Frequently talk and listen. Need to lift 1-10 lbs 1-33% of the time. Carry 11-25 lbs 1-33% of the time. Moderate noise is typical for the work environment of this job.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Manufacturing Administrative Assistant here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Associate’s Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Facilities Mechanic

Purpose: Perform a wide variety of duties in connection with the installation, repair and maintenance of building, grounds, and facility equipment.

General Responsibilities:

  • Performs scheduled and corrective maintenance of complex equipment and systems. Evaluates equipment performance and recommends improvements to the Maintenance program and system design
  • Ensure compliance with quality system procedures related to the Facility equipment and general day to day operations
  • Performs scheduled and corrective maintenance of Purified Water, Clean Steam, WFI, and Process Gasses. Maintain critical facility utilities such as boilers and steam distribution systems, air compressors and other utilities
  • Coordinates maintenance activities with manufacturing supervisors. Solicits quotations and reviews contractors’ proposals within his area of responsibilities
  • Performs periodic inspections and conducts maintenance per procedure to prevent failure of various equipment and systems
  • Performs duties with limited supervision and has the ability to work independently or in a team environment. Also has the ability to work extended hours as required
  • Troubleshoot and repair electro mechanical equipment of all types, including HVAC systems
  • Accurately and legibly document detailed description of work performed in equipment log books
  • Develop and or revise GMP and non GMP maintenance documentation (SOPs, preventative maintenance check-lists, etc.)
  • May be required to stand watch and make routine building rounds and monitor the facilities boilers in accordance with the Code of Mass. Regulations. CMR-146
  • Is required to work rotating shift and on call schedules
  • All other duties assigned by Facilities supervisor and/or manager

Knowledge and Skill Requirements:

  • Knowledge of High Pressure Boiler Systems, industrial pump/piping systems and compressed air systems
  • Knowledge of DI and DPW water systems
  • Knowledge of HVAC Systems
  • Ability to follow written and verbal instructions
  • Working knowledge of cGMP, ISO 13485 and other regulatory guidelines as appropriate

Education and Experience:
Associate's Degree or equivalent from two-year College or technical trade school; and five or more year’s field experience, including electrical and mechanical troubleshooting and repair. Equivalent professional experience may be substituted in lieu of education. Universal refrigeration license and experience with the life science industry are both a big plus. Ability to obtain a Massachusetts Second Class Fireman’s License or Special License to Operate within 1 yr is a must.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Facilities Mechanic here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Associate’s Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Medical Technologist - Beacon Diagnostic® Lab

Purpose: Perform Fungitell® testing on samples received in Beacon Diagnostic® Laboratory (BDL) based on standard operating procedures to comply with CLIA, HIPPA, HITECH and other applicable national requirements.

General Responsibilities:

  • Responsible for daily activities as they pertain to the Beacon Diagnostic® Laboratory, which entail, but are not limited to, accessioning patient samples , analyzing patient samples, reviewing data (except for NY DOH), producing reports, and invoicing customers
  • Be familiar with and follow the quality policy for ACC
  • Be familiar and follow the ACC safety policy
  • Be familiar with and follow the standard operating procedures (SOP) for BDL and ACC
  • Report results to clients following BDL SOP's
  • Interact with clients to determine their testing needs
  • Interact with clients when a sample needs to be retested
  • Proper documentation of interactions with clients
  • Maintain compliance with HIPPA and other national requirements
  • Ensure that the Fungitell® test method and standard operating procedures used to test samples from Beacon Diagnostic laboratory are current and in compliance with CLIA and other applicable guidance
  • Monitor compliance of the established policies and procedures to determine where improvements are needed and implement appropriate corrective and preventative actions
  • Utilize calibrated/certified equipment and instrumentation – notify responsible departments if equipment/instrumentation is out of calibration/certification
  • Identify samples for disposal and follow correct/appropriate disposal procedure
  • Use appropriate procedures for laboratory and biohazard waste
  • Attend training as scheduled by ACC
  • Other duties as assigned

Knowledge and Skill Requirements:

  • Excellent knowledge of CLIA, state regulations, HIPPA, and biosafety/bloodborne pathogen regulations
  • Ability to work effectively with customers and all levels of internal personnel
  • Detail oriented and excellent organizational skills
  • Able to work in a fast paced team environment
  • Excellent oral and written communications skills
  • Required to pass pipetting proficiency training and certification course
  • Other – Hepatitis B vaccination

Education and Experience:

  • A minimum of a Bachelor's Degree in a scientific or health care discipline or equivalent combination of experience and/or education required
  • Must have at least two years of experience in clinical diagnostics

General Competencies:

  • Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Information organized and accessible, maintains efficient work space, manages time well
  • Manages workload, works efficiently, and meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
  • Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

  • Constantly sit, frequently stand, and occasionally walk. Constantly use hands to finger, handle or feel. Frequently reach with hands or arms. Constantly talk or listen. Lift 1-10 lb., 1-33% of the time. Carry 1-10 lb., 1-33% of the time. Constantly exposed to fumes or airborne particles. Constantly exposed to toxic or caustic chemicals. Frequently exposed to vibration. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Medical Technologist - Beacon Diagnostic Lab here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Senior Fixed Asset Accountant

Purpose: Assists the Finance Director as a business partner responsible for fixed asset recording, valuation, accounting, timely capitalization and reporting of the company's fixed assets.

General Responsibilities:

  • Create and monitor improved system of controls, procedures and forms for recordation of fixed assets
  • Recommend any updates to accounting policies related to fixed assets
  • Develop improved processes to record acquisitions and dispositions of fixed assets
  • Track compilation of project costs into fixed asset accounts timely and accurately
  • Reconcile subledger and general ledger asset and depreciation balances
  • Investigate the potential obsolescence of fixed assets
  • Conduct periodic impairment reviews of intangible assets
  • Conduct physical counts and identification of fixed assets
  • Prepare audit schedules relating to fixed assets and assist auditors as necessary
  • Prepares journal entries, reports and adhoc requests
  • Conducts analyses, provides consulting, and makes recommendations
  • Actively support budget preparation, forecasts and analysis

Knowledge and Skill Requirements:

  • Fixed Asset Accounting Process
  • Internal Control design/improvement
  • Strong Excel Skills
  • Biopharma industry experience a plus
  • Microsoft Dynamics Great Plains a plus
  • Supports Y/E audit
  • Account reconciliation and control

Education and Experience:

  • +3 years Fixed Asset Accounting experience
  • Bachelor's Degree in Accounting/Finance, or equivalent in experience

General Competencies:

  • Reliability, integrity and commitment
  • Driven, detail oriented, creative thinker
  • Uses resources efficiently, strives to reduce cost, part of the budgeting process
  • Excellent communication skills (written and verbal), delivers presentations, has good listening skills
  • Works well with internal and external customers, strives to solve issues raised by customers
  • Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Meets deadlines, works independently, accountable, maintains focus, punctual
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Information organized and accessible, manages time well
  • Strives to eliminate errors, assess root cause and prevent recurrence
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

  • Constantly sit, frequently stand and walk. Constantly using hands to finger, handle or feel. Constantly reach with hands or arms. Occasionally stoop, kneel, crouch, and or crawl. Constantly talk or hear. Lift approximately 1-10 lbs., 1-33% of the time. Carry 1-10 lbs., 1-33% of the time. The work environment for this job is very quiet.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Senior Fixed Asset Accountant here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Senior Cost Accountant

Purpose: Assists the Finance Director as a business partner in assessing business expenses, supporting optimized budget plans, developing, updating and analyzing cost standards and variances. Performing account reconciliations.

General Responsibilities:

  • Strong analytical skills and business judgment to provide general financial support to the business
  • Collecting and analyzing data about operational/manufacturing costs
  • Develop, update, and analyze Inventory cost standards
  • Indirect support of implementation and maintenance of ERP system
  • Preparation of Account Reconciliations
  • Cycle Count Internal Controls process design
  • Prepares journal entries, reports and adhoc requests
  • Conducts analyses, provides consulting, and makes recommendations
  • Actively support budget preparation, forecasts and analysis to evaluate and predict business performance
  • Support implementation of and adherence to corporate internal control standards

Knowledge and Skill Requirements:

  • Inventory/Manufacturing/Cost Accounting
  • Internal Control design/improvement
  • Strong Excel Skills
  • Multiple Currency experience a plus
  • Biopharma industry experience a plus
  • Microsoft Dynamics Great Plains a plus
  • Supports Y/E physical inventories and reconciliation
  • Account reconciliation and control

Education and Experience:

  • +3 years Cost Accounting experience
  • Experience working within ERP environment
  • Bachelor's Degree in Accounting/Finance, or equivalent in experience

General Competencies:

  • Reliability, integrity and commitment
  • Adapts to change, open to new ideas and responsibilities
  • Uses resources efficiently, strives to reduce cost, part of the budgeting process
  • Excellent communication skills (written and verbal), delivers presentations, has good listening skills
  • Works well with internal and external customers, strives to solve issues raised by customers
  • Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Meets deadlines, works independently, accountable, maintains focus, punctual
  • Offers feedback, coach’s employees appropriately, rewards employees wisely, takes mentoring role, challenges and develops employees, offers opportunity
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Information organized and accessible, manages time well
  • Strives to eliminate errors, assess root cause and prevent recurrence
  • Meticulous, attention to detail, willing to research details & facts through hands-on approach
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

  • Constantly sit, frequently stand and walk. Constantly using hands to finger, handle or feel. Constantly reach with hands or arms. Occasionally stoop, kneel, crouch, and or crawl. Constantly talk or hear. Lift approximately 1-10 lbs., 1-33% of the time. Carry 1-10 lbs., 1-33% of the time. The work environment for this job is very quiet.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Senior Cost Accountant here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Temporary Laboratory Technician

Purpose: ASSOCIATES OF CAPE COD, INC. seeks full-time temporary workers to collect and process blood cells from horseshoe crabs to make LAL - a test for a bacterial toxin. Applicants must be hard working, careful, team players with a positive attitude. Work will last from approximately May - Mid August with a limited number of positions going into the holidays. Perfect for students or others seeking experience in the biotech field. Must be 18+ to be considered. Responsible for all functions related to Horseshoe Crab bleeding and processing

General Responsibilities:

  • Receiving crabs and unloading barrels of crabs from trucks
  • Bleeding crabs, initial cell processing, and operation of centrifuges
  • Washing and preparing all bleed related glassware
  • Assisting with preparation of Production glassware
  • Cleaning all bleed related rooms
  • Other duties as assigned by supervisor

Knowledge and Skill Requirements:

  • English language skills
  • Able to lift up to 25 lbs.

General Competencies:

  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Honest, accountable, maintains confidentiality
  • Information organized and accessible, maintains efficient work space, manages time well
  • Manages workload, works efficiently, and meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities, to improve product/services; compliant with quality system requirements
  • Accountable to team, works to meet established deliverables, appreciates view of team members, respectful

Physical Requirements:

  • Occasionally sit. Constantly stand, frequently walk. Constantly use hands to finger, handle or feel.
  • Frequently reach with hands or arms. Occasionally climb or balance. Constantly talk or hear. Occasionally taste or smell. Lift 26 to 50 lbs, 1-33% of the time. Carry 11-25 lbs, 1-33% of the time. Occasionally exposed to wet or humid conditions (non-weather). Occasionally work near moving mechanical parts. Frequently exposed to toxic or caustic chemicals. Occasionally exposed to outdoor weather conditions. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Temporary Laboratory Technician here.

In your cover letter please answer the following:

  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Fungitell® Technical Sales Specialist, Clinical Diagnostics

Location: Position will be located in either Boston, Chicago, Minneapolis, LA or San Francisco

Purpose: The Fungitell® Technical Sales Specialist, Clinical Diagnostics is responsible for identifying, nurturing, and qualifying leads into customers, by selling the company’s clinical diagnostic products and services in the US territory to help US Market meet or exceed the revenue plan. The position will provide qualified leads to the Regional Manager Clinical Diagnostics, while also being expected to support current customer inquiries including, but not limited to, providing pricing quotes and technical support.

General Responsibilities:

  • Reports to Regional Manager, Clinical Diagnostics
  • Cold-call prospects that are generated by external and internal lead sources to create and deliver qualified opportunities
  • Ensure timely follow-up of leads by capturing and communicating comprehensive customer details, calls-to-action and project timelines
  • Ability to meet target call point quotas
  • Overcome objections of prospective customers
  • Emphasize product/service features and benefits, and prepare customer sales quotations
  • Develop sales opportunities by researching and identifying potential accounts
  • Penetrate all targeted accounts and radiate sales from within client base
  • Maintain and expand the company’s database of prospects
  • Set up and deliver sales presentations, product/service demonstrations, and other sales actions
  • Timely follow up on all sales activities
  • Yearly qualification to successfully perform Fungitell® Predicate and Fungitell STAT® assays
  • Yearly qualification to successfully perform installations, and calibrations of Fungitell STAT® to support Technical Service
  • Accompany Regional Manager to occasional on-site customer visits
  • Where necessary, support marketing efforts such as trade shows, exhibits, and other events
  • Travel up to 50% of the year
  • Assisting with or performing presentations and workshop instruction at company held training courses and customer specific training courses, as required
  • Perform instrument calibrations in assigned region
  • Operate within the company approved expense budget

Knowledge and Skill Requirements:

  • Experience and knowledge of principles and practices of Sales
  • Experience and knowledge of clinical diagnostics and contract clinical testing laboratory operations
  • Proven ability to achieve and exceed sales targets
  • Demonstrate good business judgment
  • Self-starter and able to work independently
  • Interpersonal skills to build rapport with clients, communicate clearly in challenging situations and satisfy customers with issues or concerns
  • Possess excellent oral and written communication skills in addition to being an effective communicator
  • Must be skillful in presentation with strong ability in conducting negotiations in a persuasive manner
  • Ability to educate and demonstrate on the use of company products and services to potential clients and customers
  • Knowledge of customer service principles
  • Knowledge of basic business principles
  • Good working knowledge of Microsoft Word, Excel and PowerPoint
  • The Technical Sales Representative will become familiar with Company policies and procedures and present a professional image as a Company ambassador
  • Stress tolerance
  • Goal oriented
  • Must have valid driver’s license

Education and Experience:

  • Minimum of a College degree, preferably in a life science or engineering discipline, or equivalent combination of experience and/or education required
  • Two years of sales experience in biotech, medical device or pharmaceutical industry with provide sales history of growth and success

General Competencies:

  • Communicates well (written and verbal), delivers presentations, has good listening skills
  • Works well with internal and external customers, promotes a positive image of the company, strives to solve issues raised by customers
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Knows product features, understands marketplace, shares expertise with others
  • Manages workload, works efficiently, meets goals and objectives
  • Accountable to team, works to meet established deliverables, appreciates view of team members, respectful
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:
Frequently sit, stand, walk and use hands to finger, handle or feel. Occasionally reach with hands or arms, climb or balance, stoop, kneel, crouch, or crawl. Constantly talk or listen. Lift 26-50 lbs 1-33% of the time. Carry 26-50 lbs 34-66% of the time. Occasionally exposed to outdoor weather conditions. Noise level is quiet to moderate for the work environment of this job.

Updated vaccinations including Influenza, MMR, and COVID 19 required and acceptable titer determination required for full disease panel (including hepatitis A, B and C) expected for a hospital sales environment.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Fungitell® Technical Sales Specialist, Clinical Diagnostics here.

In your cover letter please answer the following:

  • Have you completed the following level of education: College Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Application Developer

Purpose: This position is responsible for the configuration management, updating and developing of modification to internal business applications including but not limited to Microsoft Dynamic, Microsoft CRM and Microsoft Business Portal. This position will also be responsible for the maintenance and development of other custom business applications.

General Responsibilities:

  • Participate in defining the strategy and vision for our internal business applications
  • Development of new and enhancement of existing internal business applications
  • Develop and maintain integrations with other business applications including CRM and ERP
  • Collaborate with Usability and designers to develop workflows and application designs
  • Work closely with end users and management to ensure a clear understanding of the business requirements
  • Develop and document requirements, functional and technical specifications
  • Work to ensure high quality for releases of our internal applications

Knowledge and Skill Requirements:

  • Must have proven experience developing high quality code
  • Experience developing and designing applications for internal usage
  • Proficiency in VB.Net, ASP.Net, PHP, SQL and Dexterity desired
  • Experience developing web applications desired
  • Proven ability in mentoring other developers and a strong commitment to team growth

General Competencies:

  • Adapts to change, open to new ideas and responsibilities
  • Communicates well (written and verbal), delivers presentations, has good listening skills
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Works well with internal and external customer, promotes a positive image of the company, and strives to solve issues raised by customers
  • Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Honest, accountable, maintains confidentiality
  • Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
  • Takes action, seeks new opportunities, and strives to see projects to completion within the job description boundaries
  • Creative, offers new ideas, risk taker, amenable to change
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Information organized and accessible, maintains efficient work space, manages time well
  • Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks
  • Strives to understand contributing factors, works to resolve complex situations
  • Manages workload, works efficiently, and meets goals and objectives
  • Monitors status of projects, thoroughly deals with project details, holds project owners accountable, and delivers clear, accurate depiction of status
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; complaint with quality system requirements
  • Defines appropriate goals, works toward achieving goals, articulates vision and steps for achievement
  • Looks for opportunities to increase knowledge, works to increase responsibility, and strives to achieve personal goals
  • Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
  • Accountable to team, works to meet established deliverables, appreciates view of team members, respectful
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Education and Experience:

  • 5+ year’s development experience
  • A minimum of a BS in Computer Science or an equivalent combination of experience and/or education required
  • Good written and oral communications skills, strong attention to detail and willingness to follow directions and established procedures with minimal supervision

Physical Requirements:
Frequently sit and stand, occasionally walk. Frequently use hands to finger, handle, or feel. Frequently reach with hands or arms, occasionally climb or balance, stoop, kneel, crouch, or crawl. Constantly talk or listen. Occasionally taste or smell. Lift 1-10 lbs. 1-33% of the time. Carry 1-10 lbs. 1-33% of the time. Frequently work near moving mechanical parts. Occasionally exposed to fumes or airborne particles, occasionally exposed to toxic or caustic chemicals. Moderate noise level is typical for the work environment of this job.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Application Developer here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor’s degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Quality Systems Specialist

Purpose: Assure compliance to ACC policies and procedures and applicable external standards. Provide recommendations to teams as they work within the different Quality System Elements, such as Design Control and investigation activities within all Quality Systems. Participate in all quality system investigations as needed, and other duties as assigned.

General Responsibilities:

  • Review Quality System Events per procedure for clarity and completeness
  • Support/Participate in Quality Event investigations, and maintain Quality Event system
  • Support investigation, corrective/preventive action and implementation of Quality Management System process improvements
  • Support investigating and coordinating other quality system assignments (Complaints, CAPA’s, Deviations, audit findings etc.) in a timely manner
  • Participate in Quality Improvement Teams, Design Control Teams, and Risk Management Teams as a representative of the Quality Department
  • Write, revise, and train on standard operating procedures for continuous improvement as assigned
  • Support MRB activities and maintenance of MRB agenda
  • Perform Quality Assurance review of quality records, reports and data
  • Perform Internal Quality System Audits as assigned
  • Perform Supplier Quality System Audits as assigned
  • Participate in FDA, ISO, Internal, Customer, audits as required
  • Perform customer, distributor, and internal requests for quality information (i.e. paper audits, general information)
  • Perform effectivity/follow up to ensure that CAPA’s and other QMS changes/updates are effective
  • Other duties as assigned, which may include, but are not limited to:
    • Department trending for reporting
    • Assist in supporting the Annual Product Review program to meet company deadlines
    • Support Management Review activities including preparation of Quality Department metrics and organization of metrics from all other areas
    • Perform training on Quality topics as needed
    • Ensure non-conforming material is handled when found, per the Management of Quality Events procedure

Knowledge and Skill Requirements:

  • Working knowledge of cGMP, ISO 13485, and other international standards
  • High attention to detail and excellent organizational skills
  • Able to work in a fast paced team environment
  • High degree of critical thinking skills
  • Excellent oral and written communication skills
  • Excellent use of Microsoft Excel (graphing techniques), Word (formatting, spelling, creating tables), PowerPoint
  • Ability to work with others and teams to resolve quality issues and ability to work independently without supervision

Education and Experience:

  • A minimum of a Bachelor’s degree or equivalent combination of experience and/or education required
  • Must have previous QA/QC experience in a regulated environment

General Competencies:

  • Adapts to change, open to new ideas and responsibilities
  • Communicates well (written and verbal), delivers presentations, has good listening skills
  • Performs tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Works well with internal and external customers, promotes a positive image of the company, and strives to solve issues raised by customers
  • Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Honest, accountable, maintains confidentiality
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Information organized and accessible, maintains efficient work space, manages time well
  • Strives to understand contributing factors, works to resolve complex situations
  • Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer choices
  • Manages workload, works efficiently, and meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
  • Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:
Constantly sit, occasionally stand, and frequently walk. Occasionally use hands to finger, handle or feel. Occasionally reach with hands or arms, occasionally climb or balance, stoop, kneel, crouch or crawl. Constantly talk. Lift 11 to 25 lbs, 1-33% of the time. Carry 11 to 25 lbs, 1-33% of the time. Occasionally exposed to toxic or caustic chemicals.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Quality Systems Specialist here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor’s degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Quality Inspector

Purpose: Work as part of the Quality Assurance Team to ensure the highest quality product in compliance with internal procedures, cGMP’s 21 CFR 820 and ISO 13485.

General Responsibilities:

  • Inspection of finished product to meet internal procedures and customer requirements
  • Level 1 and 2 inspection of raw materials per applicable material specifications
  • Write and revise procedures as necessary
  • Assist with audits (customer, FDA, and ISO) in the knowledge area of inspection activities
  • Ensure non-conforming material is handled per applicable procedure
  • Ensure quarantine areas are orderly and items are properly labeled to its status, when applicable
  • Ensure timely trending of inspection data
  • Product label verification per applicable procedures
  • Inspection of kits using ANSI/ASQZ1.4-2003 and applicable procedures
  • Quality assurance review of quality records (i.e. charts, and other associated quality records)
  • Other duties as assigned

Knowledge and Skill Requirements:

  • Use of Microsoft Word, Excel and Microsoft Outlook
  • Experience in performing quality inspections.
  • Slight lifting may be required

Education and Experience:

  • High school diploma and two years inspection experience or the equivalent combination of experience combination of experience and/or education required

General Competencies:

  • Adapts to change, open to new ideas and responsibilities
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Communicates well (written and verbal)
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Manages workload, works efficiently, and meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
  • Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner

Physical Requirements:
Occasionally sit, constantly stand and walk, constantly use hands to finger, handle, or feel. Constantly reach with hands or arms, frequently climb or balance, occasionally stoop, kneel, crouch, or crawl. Constantly talk or listen, occasionally taste or smell. Lift 11 to 25 lbs. 1-33% of the time, carry 11to 25 lbs, 1-33% of the time. Occasionally exposed to working near moving mechanical parts. Frequently exposed to fumes or airborne particles or toxic or caustic chemicals. Moderate noise is typical for the work environment of this job.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Quality Inspector here.

In your cover letter please answer the following:

  • Have you completed the following level of education: High School diploma?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Associate Manager, Facilities

Purpose: Manage the Calibration process, Asset Management Database and Quality Program requirements in accordance with internal procedures, cGMP, ISO 13485 or any other applicable local or national standards.

General Responsibilities:

  • Manage the day-to-day activities to enable the facility and equipment to sustain a state of compliance related to calibration and other scheduled activities. These activities include the review, selection and approval of appropriate calibration standards, calibration methods and intervals
  • Asset Management Database Administrator responsibilities:
    • First point of contact for end user question s and issues
    • Conduct all departmental end user trainings related to the asset management database
    • Initiate and manger applicable quality processes towards continuous improvement of the database such as: changes to existing workflows/configuration, creation of new workflows not currently implemented, integration of database information to support quarterly metrics reporting and end user process efficiencies
  • Maintain compliance of the Facilities Department to ACC Quality Program requirements
    • Responsible for ensuring Facilities Department Quality Processes Workflows (Quality Events, Change Controls, Deviations, Audit Findings, etc.) are properly initiated, executed and approved
    • Ensure completeness and accuracy of Facilities documentation and files
    • Identify procedural gaps related to Asset Management
    • Identify KPI’s and support Facilities Manager with quarterly metrics reporting
  • Collaborate with Facilities Engineers as needed
  • Support the Facility Manager with project identification and implementation. This includes participating on various project teams and acting as an SME when required
  • Support Facilities Manager with budgeting process
  • Assess employee training needs, training plan development and employee development, ensuring training compliance for the department. Continuously assess job levels, roles and responsibilities for Facilities personnel
  • Maintain consistent communication with Facilities Manager on key facility issues, potential issues and how they may be resolved, including personnel actions such as: employment, termination, disciplinary, performance and salary review
  • Perform all other duties as assigned by Facilities Manager

Knowledge and Skill Requirements:

  • Knowledge of cGMP, ISO 13485, and quality management system requirements
  • Knowledge of calibration methods and familiarity with ISO 17025 standard
  • Detail oriented, high level of accuracy, attention to detail and excellent organizational skills
  • Familiarity with mechanical systems and equipment relating to electronics, controls and building automation
  • Ability to effectively communicate across departments as well as with contracted vendors

Education and Experience:

  • Bachelor's Degree in Engineering, Facility Management, or other relevant discipline. Degree not required with 10 years relevant industry experience working in Facilities, Validation or Calibration department
  • Must have 7 years experience in a supervisory or managerial role which includes: labor productivity management, vendor management and budgeting
  • Project manager experience is a plus

General Competencies:

  • Uses resources efficiently, strives to reduce cost, part of the budgeting process
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Manages personnel resources efficiently and is continuously assessing personnel growth and training needs with a focus on team growth
  • Able to reach fact-based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Honest, accountable, maintains confidentiality
  • Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
  • Takes action, seeks new opportunities, and strives to see projects to completion within the job description boundaries
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Information organized and accessible, maintains efficient workspace, manages time well
  • Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks
  • Strives to understand contributing factors, works to resolve complex situations
  • Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer choices
  • Manages workload, works efficiently, and meets goals and objectives
  • Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; in compliance with quality system requirements
  • Defines appropriate goals, works toward achieving goals, articulates vision and steps for achievement
  • Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
  • Accountable to team, works to meet established deliverables, appreciates view of team members, respectful
  • Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

Frequently: talk, listen, sit, stand, walk, use hands or reach with hands/arms
Occasionally: climb ladder, balance, stoop, kneel, crouch, crawl, lift and/or carry 1-50lbs, work near moving mechanical parts, exposed to outdoor weather conditions and extreme cold (non-weather).
Moderate noise is typical for some work environments of this job.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Associate Manager, Facilities here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor’s Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Production Technician

2nd shift, 2pm-10:30pm

To work as a member of the Production Team to manufacture products in compliance with ACC procedures.

General Responsibilities:

  • The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), and applicable records
  • Execution of routine production operations
  • Record information into logbooks, forms or document records
  • Carry out work in a safe manner, notifying management of safety issues and risks
  • Perform scheduled cleaning of equipment/process areas
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
  • Complete required training on time
  • Perform standardization of equipment
  • Receive and distribute supplies into the production area as necessary
  • Communicate issues related to safety, quality, compliance and equipment to the Production Lead Operator and Supervisor
  • Must be able to read and follow detailed written procedures
  • Support machine change over activities
  • Assist in the assembly and disassembly of process equipment
  • Must be able to work overtime as required
  • Pay attention to floor inventory levels and communicating any deficiencies to the Lead or Supervisor
  • Other duties as assigned by supervisory staff

Knowledge and Skill Requirements:

  • Experience in manufacturing is desirable
  • Must be able to get along with and respect others
  • Be able to lift at least 25 lbs
  • Basic computer skills needed

Education and Experience:

  • A minimum of a high school diploma and 0-2 years related industry experience
  • Associates degree or equivalent is an advantage

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Production Technician here.

In your cover letter please answer the following:

  • Have you completed the following level of education: High School?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Production Lead Technician

Purpose: With minimal supervision this individual will deliver leadership and excellence in manufacturing ACC and SKK Products. The incumbent assists Management with scheduling to meet site demands and observes floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. Provide interactions with support groups/departments to ensure accurate communication and continuous flow of manufacturing processes. Provide support to integrate best practices, where appropriate, into manufacturing.

General Responsibilities:

  • Primary contact for troubleshooting and issue resolution or escalation
  • Create and follow up on work orders
  • Communicate/coordinate days scheduling and staffing plan
  • Re-allocate staff as needed during the day (breaks, lunch, training, etc.)
  • Oversight and execution of all routine and critical operations as well as commissioning and validation activities
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
  • Ensure documentation is complete, reviewed, and meets good documentation practices
  • Update SOP's as required
  • Responsible for floor inventory and communicating deficiencies
  • Recommend/implement process changes/improvements or safety/ergonomic improvements
  • Ensure work is carried out in a safe manner, notifying management of safety issues and risks
  • Responsible for interviewing candidates
  • Provide timely feedback on staff’s performance
  • Address minor personnel issues timely
  • Escalate major personnel issues to the supervisor
  • Act as a resource/subject matter expert (SME) for staff
  • Conduct training and assess effectiveness
  • Assess staff skill sets and provide feedback to supervisor
  • Must be able to work overtime as required
  • Must be able to work weekends as required
  • Other duties as assigned by supervisory staff

Knowledge and Skill Requirements:

  • Experience in manufacturing is desirable
  • Must be able to get along with and respect others
  • Be able to lift at least 25 lbs
  • Computer skills are necessary in this function
  • Act as a role model (lead by example)

Education and Experience:

  • Associates degree and 1-4 years related experience or 4-6 years industry experience or an equivalent combination of experience and/or education required
  • Bachelors of Science degree or equivalent is an advantage with 2-4 years of GMP Manufacturing experience

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Production Lead Technician here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Associates degree or related field or an equivalent combination of experience?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Senior Research Scientist

Develop a greater scientific understanding of the ACC/SKK product line and effect changes in protocols to give greater reliability with respect to products. Develop new products revolving around the current technology and new concepts leading to new technologies.

General Responsibilities:

  • Adapt and develop new technologies around the LAL system
  • Develop projects that will enhance the scientific understanding of the current products with the goal of improvement and the introduction of new products
  • Expand the range of products within the framework of ACC
  • Provide the technical expertise to conceptualize and implement new research areas
  • Provide technical support when necessary
  • Supervise Research and Development staff

Knowledge and Skill Requirements:

  • Protein Chemistry/Biochemistry including enzymology and purification
  • The use of spectroscopic, chromatographic and molecular biological techniques
  • Assay Development
  • Technology transfer and scale-up
  • Supervisory experience

Education and Experience:

  • A minimum of a PhD in Chemistry, Biochemistry or related field or an equivalent combination of experience and/or education required.
  • Several years of experience in assay development, protein chemistry and protein purification. Additional expertise in Molecular Biology and supervisor/management experience is desired.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Senior Research Scientist here.

In your cover letter please answer the following:

  • Have you completed the following level of education: PhD in Chemistry, Biochemistry or related field or an equivalent combination of experience?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Production Technician

General Responsibilities:

  • The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), and applicable records
  • Execution of routine production operations
  • Record information into logbooks, forms or document records
  • Carry out work in a safe manner, notifying management of safety issues and risks
  • Perform scheduled cleaning of equipment/process areas
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
  • Complete required training on time
  • Perform standardization of equipment
  • Receive and distribute supplies into the production area as necessary
  • Communicate issues related to safety, quality, compliance and equipment to the Production Lead Operator and Supervisor
  • Must be able to read and follow detailed written procedures
  • Support machine change over activities
  • Assist in the assembly and disassembly of process equipment
  • Must be able to work overtime as required
  • Pay attention to floor inventory levels and communicating any deficiencies to the Lead or Supervisor
  • Other duties as assigned by supervisory staff

Knowledge and Skill Requirements:

  • Experience in manufacturing is desirable
  • Must be able to get along with and respect others
  • Be able to lift at least 25 lbs
  • Basic computer skills needed

Education and Experience:

  • A minimum of a high school diploma and 0-2 years related industry experience
  • Associates degree or equivalent is an advantage

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Production Technician here.

In your cover letter please answer the following:

  • Have you completed the following level of education: High School?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Regulatory MGR / Associate Director / Director (Level Dependent Upon Experience)

Purpose: To assure regulatory compliance at Associates of Cape Cod, Inc.

Knowledge and Skill Requirements:

  • Knowledge of:
    • 21CFR, esp. Parts 210, 211, 600-610, 600's as appropriate, and 800 as appropriate
    • Canadian Medical Device Regulations, SOR/98-282
    • Directive 98/79/EC of the European Parliament and of the Council
    • FDA Guidance documents, esp. Guideline for Validation of Limulus Amebocyte Lysate Test; Changes to an Approved Application: Biological Products; Sterile Drug Products Produced by Aseptic Processing; Investigating Out-of-Specification (OOS) Test Results
    • Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice (September 2004)
    • Guidance for Industry - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (October 2006)
    • Relevant ISO documents, esp. 13485; 14971
    • Relevant EU and JP regulations
    • Relevant USP chapters
  • Good communication and writing skills
  • Project management and risk management
  • Design control

Education:

  • At least a Master's degree and three years' experience in the regulatory field or an equivalent combination of experience and/or education required
  • RAC certification preferred
  • Experience on project teams (new product development) with submissions to regulatory bodies

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Regulatory MGR / Associate Director / Director here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Master's Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.

Quality Control Analyst I

Grow your career in life sciences on Cape Cod!

In this role you will perform chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with cGMP, ACC SOPs, and FDA Analyst has working knowledge of relevant QC techniques, policies and procedures to perform QC tasks and document results. Analyst receives minimal supervision on routine assignments and detailed instructions on new assignments.

Knowledge and Skill Requirements:

  • Organizational skills
  • General laboratory skills
  • Must be detailed oriented and show proficiency in aseptic and laboratory technique
  • Ability to work independently, as well as, participate on teams comprised on immediate group members or to work cross functionally, in a fast paced laboratory environment
  • Working knowledge of cGMP, ISO 13485 quality system requirements, and principles of quality control
  • Required to pass a pipetting proficiency training and certification course.

Education and Experience:
A minimum B.S. degree in a relevant scientific discipline with 0-2+ years relevant laboratory experience within a cGMP regulated environment or an equivalent combination of experience and/or education required.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Quality Control Analyst I here.

In your cover letter please answer the following:

  • How many years of Quality Control experience do you have?
  • Have you completed the following level of education: Bachelor's Degree?
  • Are you authorized to work in the United States?
  • Must be willing to undergo a background check after an employment offer has been made.