Careers

Purpose: We are seeking a talented, collaborative and motivated Research Associate to join the Product Development team. Join us at ACC and work in a multidisciplinary environment supporting the development of new endotoxin and glucan detection products that meet ACC corporate goals using current and new technologies.

General Responsibilities:

• The major responsibilities of this position will be to support the advancement of the company product development pipeline
• Conduct laboratory experiments and studies according to approved protocols and Standard Operating Procedures (SOPs)
• Collaborate in creating SOPs, protocols for studies, verifications, and validations
• Participate in the development, improvement, verification, validation, and technology transfer of current and new products or processes
• Analyze laboratory results and prepare study reports
• Understand and follow Design Control requirements for the development of new products and processes
• Participate in cross-functional activities
• Maintain records in accordance with Quality Assurance guidelines
• Support regulatory filings for Class I and Class II in vitro diagnostic reagents and products

Knowledge and Skill Requirements:

• Experience providing analytical support for assay development activities
• Experience working as part of a cross functional team
• Experience with reagent, instrument, and software development
• Experience collaborating with external CRO/CMOs
• Experience with change management processes
• Solid knowledge of basic statistics
• Experience with data analysis and graphing programs
• Experience with automation and automated processes
• Understanding of protein and enzyme function

Education and Experience:

• A BS/MS in biochemistry, chemistry, analytical chemistry, chemical engineering, or closely related field with at least two years’ experience in industry or an equivalent combination of experience and/or education required.

General Competencies:

• Excellent written and verbal communication skills required
• Strong record keeping and organizational skills with excellent attention to detail
• Ability to work independently with minimal supervision
• Ability to manage multiple projects and priorities

Physical Requirements:

• Frequently sit, frequently stand, and walk, use hands to finger, handle or feel. Frequently reach with hands or arms, occasionally climb or balance. Occasionally stoop, kneel, crouch, or crawl. Frequently talk or listen. Frequently look at detailed information on computer screens and in printed form. Occasionally lift of carry 11 – 25 lbs. Occasionally exposed to wet or humid conditions. Frequently work near moving mechanical parts. Occasionally work in high places. Occasionally exposed to fumes, airborne particles, toxic or caustic chemicals. Occasionally exposed to uneven surface and vibration. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

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

In your cover letter please answer the following:

• Have you completed the following level of education: Bachelor of Science and/or Master of Science 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: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

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

General Responsibilities:

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

Knowledge and Skill Requirements:

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

Education and Experience:

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

Job Type: Full-Time

To Apply:

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

In your cover letter please answer the following:

• Have you completed the following level of education: High School diploma 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: Work as part of a team where needed, controlling of inventory in the Finished goods and Raw material warehouses, receiving incoming packages/shipments and fulfillment of customers’ orders.

General Responsibilities:

• Shipping;
  • Fulfillment of all Customers orders
  • Preparation of all outgoing shipments including documentation for those shipments
  • Control of all “Finished Released” product
  • Putting away all the FG material that comes over on the truck from building 1
  • Cleaning area’s when needed
• Receiving;
  • Receives/stores all materials for ACC use
  • Performs all necessary receiving transaction within Data Management System (DMS). Confirms accuracy of receipt against ACC documentation/Purchase Order
  • Receipt of Testing Services samples
  • Fulfills and completes transactions of all raw material in-house material requisitions
  • In addition to the tasks, assisting in monthly cycle counts in all areas
  • Absentee coverage where needed

Knowledge and Skill Requirements:

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

Education and Experience:

• High school diploma or equivalent or a combination of experience and education required
• 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 Logistics Technician 1 here.

In your cover letter please answer the following:

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

Purpose: 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

General Competencies:

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

Physical Requirements:

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

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Production Technician 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: 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

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: To develop a greater scientific understanding of the ACC/SKK product line and effect changes in protocols to give greater reliability with respect to products. To 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

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Uses resources efficiently, strives to reduce cost, part of the budgeting process
• Communicates well (written and verbal), delivers presentations, has good listening skills
• Perform task 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 customer, promotes a positive image of the company, and strives to solve issues raised by customers
• Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions

Physical Requirements:

• Frequently sit, frequently stand and walk, use hands to finger, handle or feel. Frequently reach with hands or arms, climb or balance. Occasionally stoop, kneel, crouch, or crawl. Frequently talk or listen. Occasionally taste or smell. Lift 11 – 25 lbs 34-66% of the time. Carry 11 – 25 lbs 34-66% of the time. Occasionally exposed to wet or humid conditions. Frequently work near moving mechanical parts. Occasionally work in high places. Frequently exposed to fumes or airborne particles, frequently exposed to toxic or caustic chemicals. Occasionally exposed to uneven surface and vibration. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

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

In your cover letter please answer the following:

• Have you completed the following level of education: A minimum of a PhD in Chemistry, Biochemistry or related field ?
• 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. Learns and executes defined QC tasks efficiently and consistently. Results are compared to specifications and documented in a timely manner. 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.

General Responsibilities:

• Technical Expertise
  • Demonstrated 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
  • Performs endotoxin testing using LAL methods (gel clot, turbidimetric, chromogenic)
  • Performs Karl Fisher, pH, container closure, testing
  • Perform standardization of Control Standard Endotoxin to Reference Standard Endotoxin
  • Prepares and reviews Certificates of Analysis
  • Formulates and tests in process solutions to determine 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 log books related to equipment and inventory, may assist in ordering of materials, reagents and supplies
• Problem Solving/Decision Making
  • Analyze and interpret study investigation results in conjunction with Supervisor. Work with Supervisor to propose next steps. Collaborate with Supervisor to implement corrective actions in response to assay and/or instrument problems
  • Contribute to discussions with the team to meet group goals
  • Identify basic technical issues, atypical and Out of Specification results, instrument malfunctions and method performance issues. Alert Supervisor and make detailed observations in support of investigations
• Planning
  • Plans execution of individual tests and activities in conjunction with Supervisor to ensure that assigned tasks are performed in a timely and efficient manner (i.e. discussing schedule conflicts with Supervisor, ensuring all material is available for use prior to testing)
  • Prepare reports as directed by Supervisor. Collaborate with Supervisor to incorporate changes/revisions as necessary in order to generate a complete report that will be ready for upper management review
• Supervision
  • Receives minimal supervision on routine assignments. Receives specific direction on new work
  • No formal supervisory responsibility
• 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 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.

General Job 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

To Apply:

Please submit a current resume and cover Quality Control Analyst I 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: 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 has mastered most or all of the fundamental quality control concepts as well as some specialized technologies and receives minimal supervision on routine assignments. Analyzes and interprets test results independently and contributes to design of new studies in consultation with Supervisor. May provide guidance and training to more junior 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
    • Proficiency is defined in the individual performance objectives,
    • 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 testing of samples with increasing complexity 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 in process solutions to determine 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 log books related to equipment and inventory, may assist in ordering of materials, reagents and supplies
• Problem Solving/Decision Making
  • • Analyze and interpret study investigation results in conjunction with Supervisor. Work with Supervisor to propose next steps. 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
    • Communicates interdepartmentally and with outside contacts to solve technical issues as directed by Supervisor
    • When conducting testing, if SOP's or test methods (e.g. Method of measuring pH) are not optimal, propose ideas for development and optimization in order improve compliance, efficiency and/or reduce cost (e.g. Align current procedures with current practices, consolidate forms or procedures, recommend purchase of new equipment or instrument to upgrade or replace obsolete model). Present idea to Supervisor for approval.
    • Begins to 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.
• 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 review. Collaborate with Supervisor to incorporate changes/revisions as necessary in order to generate a complete report that will be ready for upper management review.
• Supervision
  • • Receives overall direction from Supervisor and carries out test without supervision.
    • No formal supervisory responsibility
    • May provide training to 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/ 2-4+ 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/ 0-2+ 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

To Apply:

Please submit a current resume and cover Quality Control Analyst II 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: 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

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.