Careers

Purpose: Maintain document control systems and activities; administration of the electronic Quality Management Systems (eQMS); manage support activities for eQMS; manage training within the Learning Management System (LMS). Manage Document Control functions and activities.

General Responsibilities:

• System Administrator for the electronic Quality Management Systems (eQMS)
• Manage support activities for eQMS
• Manage all document control activities per procedure
• Responsible to ensure that the ACC document control system and training program is in compliance with all applicable standards and guidelines
• Manage training within the Learning Management System (LMS)
• Maintain document control databases such that they are up to date and accurate at all times
• Perform training as required
• Review, approve and release Quality Records such as product history records and manufacturing records and certificates as needed
• Prepare for and participate in customer, regulatory and internal audits
• Support the generation monthly metrics and reports as needed
• Participate in project teams and change controls as the Document Control representative
• Participate in change management process
• Other duties as assigned

Knowledge and Skill Requirements:

• Working knowledge of cGMP, ISO 13485, IVDD, IVDR and other international standards and guidances 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:

• 5 years' experience working within a quality system and regulated environment
• 3+ years working in a Documentation Control function preferred
• A minimum of a Bachelor's degree or equivalent combination of experience and/or education required

General Job Competencies:

• Communicates well (written and verbal), delivers presentations, and 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
• Meet deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Honest, accountable, maintains confidentiality
• 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
• 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, 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

Salary: $70,000-$75,000 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

To Apply:

Please submit a current resume and cover Supervisor, Document Control here.

In your cover letter please answer the following:

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

Purpose: Ensures compliance to ACC policies and procedures and applicable external standards for product development, quality control, and manufacturing. Ensures compliance and provides recommendations to teams as they work within the different Quality Systems such as investigation activities within Quality System Events. Manages activities assigned as the Quality Assurance Supervisor.

General Responsibilities:

• Provide support, leadership and guidance for direct reports
• Participate in the audit program, internal, supplier, customer, regulatory and mail audits, including coordination of mail audits/surveys within the group
• Participate in Product release activities as needed including the review, approval and release of Quality Records such as product history records and manufacturing records and certificates
• Participate in the review and approval of Contract Test Service reports as needed
• Provide support, leadership and guidance on the Quality System, specifically as it pertains to Quality System Regulations and per defined procedures
• Participate in the Annual Product Review process including creation of the Annual Product Review Reports
• Support ProcessCompliance activities in eQMS such as Quality System Events, Complaints, Change Controls, Audit Findings, CAPAs
• Review standards and guidelines for compliance and participate in the standards review process as needed
• Participate in cross-functional project teams to support new product development, design changes, computer system implementation, and quality system improvements as needed
• Provide support for 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 and associated activities as needed
• Support and participate in FDA and Notified Body Audits and manage findings as assigned
• 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's degree in a science-related field or an equivalent combination of experience and education required.

General Job Competencies:

• Adapts to change, open to new ideas and responsibilities
• Communicates well (written and verbal), delivers presentations, and 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

Salary: $82,000-$87,000 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

To Apply:

Please submit a current resume and cover Supervisor, Quality Assurance here.

In your cover letter please answer the following:

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

Purpose: 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.

Education and Experience:

• Minimum of 3 years of high school, or more; 1 yr. of college preferred or an equivalent combination of experience and/or education required

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 and/or Part-Time

Salary: $18.00-$19.00 per hour

To Apply:

Please submit a current resume and cover Temporary LAL Production Technician (May-November) 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.

Purpose: Perform a wide variety of duties in connection with the installation, repair and maintenance of building, grounds, and facility equipment. Duties include performing scheduled maintenance procedures, lubricate equipment, change filters, making adjustments and troubleshooting as required. Assist with all aspects of remodeling/renovation of office, laboratory, general office space, and manufacturing areas. Coordinate and track work assignments. Responsibilities also include being on call for emergency services as required, and willingness to work, based on the need of internal customers.

General Responsibilities:

• Properly monitor the facilities boiler in accordance with the Code of Mass. Regulations. CMR-146. This includes standing watch in a 24/7 environment on either a fixed or rotating schedule
• Make rounds every two hours of the mechanical room and the air handling room, checking for any problems with the machinery
• Perform unscheduled and preventive maintenance building and facility and production equipment such as; DPW, clean steam generator, RO/DI systems. glass washers, autoclave, processing tanks, air compressors, filtered gas system, and other manufacturing equipment
• Train new employees as required for preventive maintenance procedures and calibration
• General facility upkeep such as repairing doors, walls, floors, ceilings and other related building duties
• Completes work orders as assigned
• Organizes and maintains inventory of all supplies needed for maintenance
• Interact with building contractors and help them achieve their goals
• Contacts vendors and solicits bid as necessary
• Prepares purchase orders for repairs and supply parts
• Develops departmental standard operating procedures and maintains GMP and non-GMP equipment history files
• Manages small to medium size capital projects by leading project teams
• Participates in off-hours emergency coverage, as needed
• Perform other duties and responsibilities as assigned by immediate supervisor
• Assist with equipment and calibration contractors
• Responsible for monitoring Process and Utility systems and equipment to ensure continuous efficient and reliable operations
• 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
• This position requires regular travel between our East Falmouth, MA and Mansfield, MA facilities

Knowledge and Skill Requirements:

• Ability to follow written and verbal instruction
• Excellent interpersonal skills
• Demonstrated knowledge of shop math
• Knowledge of High Pressure Boiler Systems
• Knowledge of Di and DPW water systems
• Knowledge of HVAC Systems
• Ability to follow written and verbal instructions

Education and Experience:

• A minimum of a High school diploma or equivalent education or a combination of experience and education required. Second fireman’s license (preferred)
• Minimum of 10 years experience in equipment maintenance work and coordinating with other trades (mechanical, electrical, HVAC and plumbing) for job continuity

Physical Requirements:

• Occasionally sit, frequently stand, walk, and use hands Frequently reach with hands or arms, climb or balance, stoop, kneel, and crouch, or crawl. Frequently talk or listen. Lift 26 to 50 lbs. 1-33% of the time. Carry 26 to 50 lbs. 1-33% of the time. Occasionally exposed to wet or humid conditions (non-weather). 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. Occasionally exposed to outdoor weather conditions. Occasionally exposed to extreme heat (non-weather). Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

Salary: $75,000-$80,000 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

To Apply:

Please submit a current resume and cover Senior Facilities Mechanic 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.

Purpose: This Supply Chain Management (SCM) position is responsible for leading the Inventory cycle counting (CC) program at ACC within the established procedures and processes. This would include being on hand during the CC process and to develop and maintain a Quarterly analysis of the items counted and yearly ABC analysis. This position is responsible for providing support in the data management of Lysate inventory, continuously monitoring lysate storage space capacity, understanding and supporting the quarterly analysis of Lysate inventory levels, and facilitating movement of frozen inventory to the approved off-site storage location. This position would also have responsibilities within the eDMS to function as the initiator for Quality Events and Change Controls for the Supply Chain department. Additional responsibilities may be within the procurement process as backup to place maintenance, repair, and operations (MRO) purchase orders for expense items (Kanban), aided with the compliance of purchasing SOP’s for placement of inventoried raw materials, and for providing support with supplier qualification and monitoring. Provide a high quality of service and ethics. This role works closely with the Production Planning Manager, Logistics Manager, Senior Production Manager, LAL Manufacturing Manager, and Materials Planning Supervisor.

General Responsibilities:

• Implementation of the Cycle Count process within the established ACC procedures – must work closely with SCM, Production, and QA Departments
• Reconciliation of all Cycle Counts found to be discrepant during the cycle counting process
• Generate and maintain a detailed analysis of the items CC’d during each financial quarter
• Develop competency and independence with planning and coordinating the annual Physical Inventory at fiscal year end
• Develop competency and independence within ACC’s Data Management System (DMS) as it relates to bills of material, routings, and item masters
• Participate in the development, update, and implementation of SOP’s to support the Inventory Management function
• Maintain departmental metrics related to the Inventory Management function
• To accurately maintain the DMS through the posting of Transactions (i.e. Adjustments and Variances), Transfers, and Bin Transfers within the reporting period
• Support a detailed analysis of Lysate inventory, storage capacity, and off-site movements
• Support data management of Lysate inventory – must work closely with Production, Bleed, and QC Departments
• Participate in the development, update, and implementation of SOP’s to support the SCM and Purchasing departments
• Develop competency and independence within ACC’s eQMS as it relates to quality events and change controls
• Other activities (i.e. investigations, complaints, etc.) to aid in the support of the SCM team as assigned

Secondary Responsibilities:

• Support purchasing as required
• Support material planning as required
• Support logistics as required

Knowledge and Skill Requirements:

• Above average skills using MS Office products Word & Excel
• Exposure to a Data Management System (preferably Microsoft Dynamics GP)
• Knowledge of the supply chain process
• Ability to do multiple data analysis
• Ability to build effective relationships with internal customers
• Ability to work with online Quality Management and Document Control Systems (preferably Qumas)
• Effective working in a team environment
• Close interaction with a wide range of personalities
• Detail oriented
• Strong organizational skills
• Good communications skills
• Able to work independently or as part of a team within a fast-paced deadline environment
• Ability to lift at least 25 lbs.
• Ability to multitask
• Ability to be flexible and shift direction easily

Education and Experience:

• A minimum of a college degree (is preferable) or an equivalent combination of experience and education required.
• 2-3 years’ experience working in manufacturing preferably in a medical device or pharmaceutical environment.
• Experience with cGMP and ISO-9001 or 13485 quality systems are preferred.

General Competencies:

• 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
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• 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

Physical Requirements:

• Frequently sit, occasionally stand and walk. Constantly use hands to finger, handle, or feel. Occasionally reach with hands or arms. Constantly talk or listen.
• Lift 11-25 lbs., 1-33% of the time. Carry 1-10 lbs. 1-33% of the time. Frequently exposed to extreme cold (non-weather). Occasionally exposed to outdoor weather conditions. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

Salary: $56,500-$61,500 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

To Apply:

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

In your cover letter please answer the following:

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

Purpose: Responsible for all phases of the procurement process within ACC’s procedures. This includes assurance of the supply of critical raw materials and operating supplies, effective negotiation of contracts for services, development of a reliable supplier base and ensuring 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 and release purchase orders in support of the Production Plan. This includes raw materials, operation supplies and critical services
• Generate / maintain detailed reports of purchasing requirements and purchase material status
• Provide product availability information to Customer Service, Materials Planning, and the Production Planning Manager for purchased finished goods
• Utilizing various planning data (Sales and Operation Planning, MRP/Reorder Point data), provide management with detailed analysis of material requirements as required
• Assist with sourcing new materials and suppliers
• Negotiate favorable terms and price reductions while maintaining ACC quality objectives
• Ensure the purchasing function maintains compliance to ACC quality systems
• Develop and update SOPs to support the purchasing function
• Support accurate information systems (i.e. Material Specification and Item Master data) through the Change Control Process
• Provide purchasing, inventory, shipping/receiving related KPI’s to management as needed
• Support the supplier approval and monitoring process
• Support the processing of yearly physical inventories

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 an AS 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
• ASCM or C.P.M. certification preferred
• Experience with cGMP and 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

Salary: $55,000-$58,000 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

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: AS in a business discipline or equivalent combination?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

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:

• Accurately process and manage complex customer orders through ERP/CRM systems
• Coordinate with manufacturing, sales, and technical service to ensure timely fulfillment
• Provide professional customer support and resolve issues promptly to retain customer loyalty
• Maintain accurate account records, invoicing, and billing documentation
• Monitor inventory status and proactively communicate with customers and internal teams

Knowledge and Skill Requirements:

• Hands-on experience with ERP/order management systems (SAP, Microsoft Dynamics, Oracle, or similar)
• Strong organizational skills, attention to detail, and a proven work ethic
• Excellent written and verbal communication skills
• Self-starter, highly motivated with the ability to multitask in a fast-paced environment
• Willing to learn new technologies
• Microsoft Excel, Word
• Knowledge of ACC products

Education and Experience:

• 3–5 years of customer service experience in a B2B or regulated industry (life sciences, pharma, or medical device preferred)
• Must have a minimum of a High School diploma; Bachelor’s degree preferred; or equivalent combination of experience and education required

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, maintain 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 is organized and accessible, maintains an efficient workspace, 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

Salary: $22.00 per hour
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

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 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.

Purpose:To maintain and monitor boiler and building systems in accordance with Massachusetts laws.

General Responsibilities:

• Properly monitor the facilities boiler in accordance with the Code of Mass. Regulations. CMR-146. This includes standing watch in a 24/7 environment on either a fixed or rotating schedule
• Make rounds every two hours of the mechanical room and the air handling room, checking for any problems with the machinery
• Performing preventive maintenance on facility equipment and production equipment as needed and in accordance with FDA and cGMP guidelines
• Troubleshoot any problems and take corrective actions for machinery, water systems and production equipment throughout the building
• Answer and troubleshoot alarms from the Building Management System
• Take water samples of the clean steam system, DPW system, and take TOC readings on the DI and Clean Steam System
• All duties assigned by supervisor

Knowledge and Skill Requirements:

• Knowledge of High Pressure Boiler 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:

• Minimum of a High School Diploma or equivalent education or a combination of experience and education required
• Second class fireman’s license or greater (required)

General Competencies:

• Adapts to change, open to new ideas and 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
• 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
• 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
• 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; complaint 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:

• Occasionally sit. Frequently stand and walk. Frequently use hands. Occasionally reach with hands or arms, climb or balance, stoop, kneel, crouch, or crawl. Occasionally talk or listen. Lift 26-50 lbs. 1-33% of the time. Carry 26-50 lbs. 1-33% of the time.
• Frequently exposed to wet or humid conditions (non-weather). 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. Occasionally exposed to outdoor weather conditions, extreme heat (non-weather). Work environment is loud for this job.

Job Type: Full-Time

Salary: $64,000-$67,000 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

To Apply:

Please submit a current resume and cover letter for Boiler Operator here.

In your cover letter please answer the following:

• Have you completed the following level of education: High School Diploma or equivalent 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.

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

General Responsibilities:

• Properly monitor the facilities boiler in accordance with the Code of Mass. Regulations, CMR-146. This includes standing watch in a 24/7 environment on either a fixed or rotating schedule
• Make rounds every two hours of the mechanical room and the air handling room, checking for any problems with the machinery
• Responsible for monitoring Process and Utility systems and equipment to ensure continuous efficient and reliable operations
• 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.)
• Properly monitor the facilities boiler in accordance with the Code of Mass. Regulations. CMR-146
• All other duties assigned by Facilities supervisor and/or manager

Knowledge and Skill Requirements:

• Knowledge of High Pressure Boiler 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:

• A minimum of an Associate's Degree from two-year College or technical trade school or an equivalent combination of experience and/or education required
• Five or more year’s field experience, including electrical and mechanical troubleshooting and repair
• Equivalent professional experience may be substituted in lieu of education, especially if within the field service industry for HVAC
• 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

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Perform tasks with a computer. Email, research, and interact 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
• 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
• 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
• 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; complaint 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:

• Occasionally sit, frequently stand and walk, and use hands. Frequently reach with hands or arms, climb or balance, stoop, kneel, and crouch, or crawl. Frequently talk or listen. Lift 26 to 50 lbs 1-33% of the time. Carry 26 to 50 lbs 1-33% of the time. Occasionally exposed to wet or humid conditions (non-weather). 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. Occasionally exposed to outdoor weather conditions. Occasionally exposed to extreme heat (non-weather). Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

Salary: $50,000-$61,000 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

To Apply:

Please submit a current resume and cover Facilities Mechanic here.

In your cover letter please answer the following:

• Have you completed the following level of education: Associate's Degree from two-year College or technical trade school 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.

Purpose: Performs 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 current Good Manufacturing Practices, Associates of Cape Cod Standard Operating Procedures, compliance guidelines of the FDA and other regulatory bodies, and approved license requirements. Results are compared to specifications and documented. Analyst is technically independent and has mastered fundamental quality control concepts as well as some specialized technologies. Independently coordinates activities with others both inside QC and outside the department and carries out projects with minimal supervision. Displays initiative and technical commitment and independence for study design. Organizes and provides written and/or oral presentations of work with minimal input from Supervisor. Displays ability to perform more complex studies and to make independent contributions to the development of new technologies. Provides guidance and training to other staff members.

General Responsibilities:

• Technical Expertise
  • Must demonstrate proficiency in performance of test methods, analysis of data and provide general laboratory support per approved procedures
    • Test methods may include (but are not limited to):
      • Environmental Monitoring
        • Sample collection and associated testing of ISO Class 5, 7, 8, Laminar Flow Hoods, Biosafety Cabinets and critical utilities including the water systems
        • Perform Growth Promotion testing of microbiological media
        • Perform Plate reading, streaking, gram staining, and microbial ID
        • Perform Sterility Testing
      • Product Release and Stability Testing
        • Perform routine Quality Control testing of raw materials, in process and final products in accordance to SOP's
        • Perform complex testing in accordance with written protocols
        • Performs endotoxin testing using LAL methods (gel clot, turbidimetric, chromogenic)
        • Performs Karl Fisher titration for moisture
        • Performs pH determination
        • Performs container closure testing
        • Perform standardization of Control Standard Endotoxin to Reference Standard Endotoxin
        • Prepares and reviews Certificates of Analysis
        • Formulates and tests feasibilities for final product ratios
    • Data Analysis
      • Perform calculations; interpret results and record data in a timely manner, as defined in performance objectives, ensuring all documentation is accurate and complete.
    • General Lab Support
      • Test sample management and handling, maintenance of lab equipment and log books, assist in ordering materials/reagents and supplies, and maintain cleanliness and safety of the laboratories
      • Participate in safety, customer, and quality audits including answering questions during tours
      • Maintain and review log books related to equipment and inventory, may assist in ordering of materials, reagents and supplies
      • May be responsible for coordination of intra and/or interdepartmental activities
      • Participate in safety, customer, and quality audits including answering questions during tours and providing written responses to audit findings as assigned
• Problem Solving/ Decision Making
  • • Technically independent and contributes substantially to the interpretation of results and design of follow up studies. Propose next steps to Supervisor for approval prior to execution. Propose corrective actions in response to assay and/or instrument problems to Supervisor for review prior to implementation
    • Contribute to and when assigned lead discussions with the team (either in or out of lab meeting) to meet group goals
    • Independently communicates interdepartmentally and with outside contacts to solve technical issues and communicates results to Supervisor
    • Proactively investigate and troubleshoot Quality Control Methods and SOP's to improve compliance, efficiency and/or reduce cost (e.g. recommend purchase of new equipment or instrument to upgrade or replace obsolete model, identify new alternative methodology/technologies , performing gap analysis to ensure alignment with cGMP or regulatory guidance's) . Present idea to Supervisor for approval
    • Utilize colleagues and literature to solve complex problems
    • Identify basic technical issues, atypical and Out of Specification results, instrument malfunctions and methodology problems. Alert Supervisor and make detailed observations in support of investigations
    • Review departmental paperwork/data for compliance to procedures and specifications, identifying trends, aberrant results and potential cGMP violations to assist department as needed
    • Represent QC at cross functional meetings as assigned in a leadership capacity (this includes disseminating information in a professional manner with the groups goals represented)
• Planning
  • • Plans sequencing of individual (or group as needed) tests and activities and communicate plan to Supervisor to ensure that assigned tasks are performed in a timely and efficient manner (e.g. discussing schedule conflicts with Supervisor, ensuring all material is available for use prior to testing)
    • Prepare reports independently and submit to Supervisor for approval. Reports should be ready for upper management review at time of submission to Supervisor
    • Prepare metrics reports including statistical analysis of results when required
    • Prepare training plans when required
• Supervision
  • • Receives overall direction from Supervisor and carries out test without supervision.
    • May supervise junior staff members
    • Provides training of other staff members
• Perform other additional job related duties as required

Key responsibilities may differ among employees with the same job title and may change over time in accordance with business needs.

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 of a B.S. degree in a relevant scientific discipline w/ 4-6+ years of laboratory experience within a cGMP regulated environment or an equivalent combination of experience and/or education required.
• M.S. degree preferred in a relevant scientific discipline w/ 4+ years of laboratory experience within a cGMP regulated environment.

General Competencies:

• 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
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• 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
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

Frequently sit, constantly stand, walk, use hands to finger, handle, or feel. Constantly reach with hands or arms. Frequently climb or balance. Frequently stoop, kneel. Must be able to hear and communicate verbally. Lift > 25 lbs. 10% of the time above shoulder. Carry 1-10 lbs. frequently above shoulder. Occasionally exposed to wet or humid conditions (non-weather). Frequently work near moving mechanical parts. Occasionally exposed to fumes or airborne particles. Frequently work with toxic or caustic chemicals. Occasionally exposed to vibration. Moderate noise is typical for the work environment of this job. Fine motor skills and dexterity are required in order to pipette small volumes (need a steady hand).Ability to type using a computer keyboard is required. Personnel cannot have a skin condition, upper respiratory illness, or allergic reaction that causes excessive sneezing, itching, or scratching. Exposure to the laboratory area and controlled cleanroom environments, where the use of personal protective equipment such as safety glasses, lab coats, gloves, gown, and facemasks is required.

Job Type: Full-Time

Salary: $49,000-$65,000 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

To Apply:

Please submit a current resume and cover Quality Control Analyst III here.

In your cover letter please answer the following:

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