Careers

Kitting Technician - Temporary to Permanent

Purpose: Work as part of a team where needed, in the Finished goods and Raw material warehouses, packaging final product for sale, and fulfillment of customers' orders.

General Responsibilities:

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.

Knowledge and Skill Requirements:

  • Strong organizational skills
  • Detail oriented
  • Good communications skills
  • Working computer knowledge

Education and Experience:

  • High school diploma or equivalent
  • Working in a high paced deadline environment
  • Close interaction with a wide range of personalities

General Competencies:

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

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 Kitting Technician 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.

Quality Assurance Manager

Purpose: Management of all product disposition activities to ensure that product released has met all predetermined requirements and is released per ACC procedures. Oversight of the training functions to ensure compliance with ACC procedures and appropriate regulations. Responsibilities include ensuring the Quality Management System is compliant to ISO 13485, 21 CFR 820 and internal procedures.

General Responsibilities:

  • Maintain and support ACC’s quality management system to ensure it meets 21 CFR Part 820, ISO 13485 and customer expectations
  • Oversight of Quality Assurance disposition functions
  • Oversight of Quality training functions
  • Support quality record review of the following documents as the quality assurance representative or designee for the Director of Quality where indicated:
    • Level 1, 2 and 3 procedures
    • Validation protocols and reports
    • NCRs, CAPAs and SCARs as designee
    • QC test data review
    • CTS test data review
  • Manage the following Quality System Programs:
    • Product disposition
    • Receiving Inspection
    • Final Inspection
    • Annual Product Review (APR)
    • Supplier Audits
    • Customer Audits
    • Supplier Corrective Action Program
    • Customer Surveys and customer requests for information regarding quality at ACC
    • Training
  • Support the following Quality System Programs:
    • Customer Complaints
    • Internal Audits
    • FDA and Notified Body Audits
    • Nonconformance’s
    • Corrective and Preventive Action
  • Perform training on quality-related issues
  • Other major projects and duties as assigned
  • Update SOPs as necessary
  • Respond to quality system-related issues in a timely manner

Knowledge and Skill Requirements:

  • 5+ years experience in an ISO/FDA regulated industry, biologics experience preferred
  • 5+ 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.

Supply Chain Manager

The Supply Chain Manager is responsible for material supply and control. Through sales, inventory and manufacturing analysis he/she will generate a master schedule which will in turn drive purchasing of raw materials and/or services in support of the production plan. Inventory levels will also be calculated based on replenishment lead times, expiration dating and obsolescence.

General Responsibilities:

  • Manage purchasing, planning, warehousing and inventory control in accordance with ACC's quality system
  • Generate and maintain the master production schedule
  • Lead the installation and ongoing system management of the MRP module of Great Plains
  • Direct interface with finance associated with BOM accuracy, excess and obsolete inventory and purchase price
  • Oversee warehouse operations ensuring a high degree of inventory accuracy through proper inventory transactions and consistent cycle counting
  • Develop “power user” skills associated with the Great Plains business management system
  • Communicate material needs to purchasing
  • Train warehouse personnel on proper SOPs and Great Plains transaction process
  • Organize and manage physical inventories at least once and possibly twice per year
  • Assist in the generation and overall effectiveness of the work center production plan

Knowledge and Skill Requirements:

  • Strong management and training skills
  • Business management system software and MRP experience
  • Familiar with cost accounting principles
  • Above average spread sheet skills
  • Experience with GMPs and ISO based system management

Education and Experience:

  • A minimum of a BA or BS in a business discipline or an equivalent combination of experience and/or education required
  • 5-8 years planning or purchasing experience preferable in a medical device or pharmaceutical environment
  • APICs certification a plus

General Competencies:

  • Communicates well (written and verbal), delivers presentations, has good listening skills
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Offers feedback, coach’s employees appropriately, rewards employees wisely, takes mentoring role, challenges and develops employees, offers opportunity
  • Honest, accountable, maintains confidentiality
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Provides strong leadership, sets a good example, skilled decision maker, motivator, encourager
  • Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Supply Chain Manager here.

In your cover letter please answer the following:

  • Have you completed the following level of education: BA or BS in a business discipline or equivalent combination of relevant experience and education?
  • 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.

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.

Systems Administrator III

The purpose of the Systems Administrator III is to ensure uptime, performance, and security of computer systems primarily focused on servers, switches, routers, firewalls, and data solutions for Associates of Cape Cod, Inc.

General Responsibilities:

  • Perform installation, configuration, qualification, maintenance and troubleshooting of information systems, applications and related hardware and firmware
  • Provide technical support for both hardware and software issues to end-users
  • Review system logs to proactively mitigate issues and maintain security
  • Maintain systems documentation
  • Assist in periodic performance/metric reporting
  • Provide basic training to end-users in operation of equipment and applications
  • Provide on-call/after-hours support for critical computerized systems, Potential weeknights, weekends and or Holiday coverage
  • Author and maintain information technology company-wide policies
  • Lead and manage IT projects to support various business functions
  • Provide guidance to less experienced team members

Knowledge and Skill Requirements:

  • Extensive knowledge in Microsoft operating systems (Windows 10 & Server 2008-2019)
  • Extensive knowledge in Microsoft Server applications including IIS, Exchange and SQL
  • Extensive knowledge of Active Directory and Group Policies
  • Extensive understanding of computer networking concepts, protocols and services
  • Extensive knowledge of batch or powershell scripting
  • Extensive knowledge of cloud computing platforms (Azure/AWS preferred)
  • Extensive knowledge of virtualization solutions (VMware ESXi, Hyper-v, Xen, and Citrix preferred)
  • Experience in Office 365
  • Experience with Microsoft System Center Configuration Manager (SCCM) and Intune
  • Experience in administering Unix/Linux operating systems
  • Experience in administering Oracle database solutions
  • Knowledge of project management best practices and methodologies
  • Ability to research and solve complex technical issues
  • Detail-oriented and excellent organizational skills
  • Ability to effectively communicate and explain detailed and/or complicated technical issues in terms that benefit users and help resolve problems and issues
  • Ability to manage multiple projects and ensure deadlines are met
  • Ability to follow rules, regulations and guidance required in FDA and ISO regulated environments

Preferred Qualifications:

  • Any current technology certification (A+, Network+, Security+, MCTS, MSCA, ITIL etc.)
  • Information Technology Service Management tool set experience
  • SOX, 21 CFR Part 11, GDPR, GxP and/or HIPAA experience

Education and Experience:

  • A minimum of a Bachelor’s degree preferably, but not required in computer science or a related field or an equivalent combination of experience and/or education required
  • Seven or more years related experience in systems administrator, hardware maintenance such as configuring, installing and troubleshooting servers, workstations, and network related equipment
  • Biotechnology, life science, pharmaceutical or healthcare industry experience is preferred

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Systems Administrator III here.

In your cover letter please answer the following:

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

LAL Production Technician

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:

  • 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 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.

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.

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.

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.

CTS  Analyst

General Responsibilities:

  • Perform testing using each of the three LAL (limulus amebocyte lysate) methods-gel clot, turbidimetric & chromogenic
  • Interpret results, perform pipetting
  • Report writing, interact with clients relative to sample testing
  • Database entry
  • Utilize calibrated/certified equipment & instrumentation,
  • Maintain certification in all three LAL methods

Knowledge and Skill Requirements:

  • 1 years exp. in a lab environment
  • Strong organizational skills
  • Must be detail oriented with good aseptic/laboratory technique
  • Possess the ability to work independently as well as with others in a fast paced environment
  • Excellent oral & written communication skills
  • Possess a working knowledge of cGMP, ISO 9001, ISO 13485 & internal operating procedures
  • Required to pass a pipetting proficiency training and certification course.
  • Other – Hepatitis B vaccination

Education and Experience:

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

Product Development Associate

General Responsibilities:

The major responsibilities of this position will be to support the advancement of the company clinical product development pipeline while using various laboratory equipment for routine analyses (e.g., spectrophotometers, manual pipettes and automated liquid handlers etc)

  • Participate in the development, improvement and validation of new assays
  • Design, write and carryout experimental protocols.
  • Test analytical and clinical samples
  • Analyze laboratory results and prepare study reports.
  • Support regulatory filings for Class I and Class II in vitro diagnostic reagents and products.
  • Follow Design Control requirements and SOPs in a GMP environment.
  • Maintain records in accordance with Quality Assurance Guidelines.
  • Participate in cross-functional activities.

Education and Experience:

The position requires a minimum of BS/MSc in Biochemistry, Chemistry or Biology with 5 years of relevant industry experience or equivalent combination of education and/or experience. 

General Competencies:

  • Scientific creativity, critical thinking, ability to innovate, and analytical problem solving.
  • Ability to accurately follow, draft and review technical documents, including test plans, protocols and reports.
  • Ability to work independently, as well as, with others in a fast paced laboratory environment.
  • Willing and able to drive projects to completion and to meet deadlines
  • Excellent written and oral communication skills.
  • Proficiency in software applications such as Word, Excel, PowerPoint.
  • Excellent use of manual, multichannel, and repeater pipettes. Able to accurately dispense small volumes consistently.
  • Hands-on experience with the use of automated liquid handling system is a plus
  • Other – Hepatitis B vaccination to be able to test clinical samples.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Product Development Associate here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor of Science 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.

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.