Careers

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

General Responsibilities:

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

Knowledge and Skill Requirements:

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

Education and Experience:

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

General Competencies:

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

Physical Requirements:

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

Job Type: Full-Time

To Apply:

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

In your cover letter please answer the following:

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

Purpose: Ensure compliance to external, FDA, ISO, MDD, CMDR, and internal Quality Standards and procedures for product development and manufacturing. Provide support and participate in all quality system investigations as needed, and other duties as assigned.

General Responsibilities:

• Responsible for managing the complaint handling process including database maintenance, investigating complaints, coordinating, and resolving complaints in a timely manner and reporting on complaint metrics
• Lead/participate in Quality Event investigations, and maintain Quality Event system
• Write, revise, and train on standard operating procedures for continuous improvement
• Support Quality System Compliance by performing internal audits of the Quality System as assigned
• Perform supplier audits as assigned
• Lead investigation, corrective/preventive action and implementation of Quality Management System process improvements
• Participate in Quality Improvement Teams, Design Control Teams, and Risk Management Teams as a representative of the quality department
• Responsible for investigating and coordinating other quality system assignments (CAPA’s, NCR’s, audit findings etc.) in a timely manner
• Managing customer, distributor, and internal requests for quality information (i.e. paper audits, general information)
• Manage effectivity/follow up program to ensure that CAPA’s and other QMS changes/updates are effective
• Participate with FDA, ISO, internal, customer and supplier audits
• Other duties as assigned, which may include, but are not limited to:
  • Department trending for reporting
  • Assist in supporting the Annual Product Review program to meet company deadlines
  • Coordinate Management Review activities including preparation of Quality Department metrics and organization of metrics from all other areas
  • Perform training on Quality topics as outlined in yearly training schedule
  • Ensure non-conforming material is handled when found, per the Non-conforming Material procedure
  • Quality Assurance review of quality records

Knowledge and Skill Requirements:

• Strong working knowledge of 21 CFR 820, 210, 211, 600, ISO 9001:2008, and ISO 13485
• High attention to detail and excellent organizational skills
• Able to work in a fast paced team environment
• High degree of critical thinking skills
• Excellent oral and written communication skills
• Excellent use of Microsoft Excel (graphing techniques), Word (formatting, spelling, creating tables), PowerPoint, and Access
• Ability to work with others and teams to resolve quality issues and ability to work independently without supervision

Education and Experience:

• Bachelor’s degree in life science and 5 years of experience in the biotechnology or pharmaceutical industry or an equivalent combination of education and experience required.

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Communicates well (written and verbal), delivers presentations, has good listening skills
• Performs tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slidepresentation (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
• onest, accountable, maintains confidentiality
• Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
• Information organized and accessible, maintains efficient work space, manages time well
• Strives to understand contributing factors, works to resolve complex situations
• Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer choices
• Manages workload, works efficiently, and meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
• Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

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

Job Type: Full-Time

To Apply:

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

In your cover letter please answer the following:

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

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

General Responsibilities:

• Scientific review of testing, results, and reports for each of the three LAL methods (gel clot, turbidimetric, and chromogenic) and Glucatell to ensure the original records were reviewed for accuracy, completeness, and compliance with SOP’s
• Peer review of monthly laboratory logs for accuracy, completeness, and compliance with SOP’s
• Be familiar with the quality policy for ACC
• Be familiar and follow the ACC safety policy
• Be familiar with and follow the standard operating procedures (SOP) for ACC
• Report preliminary results to clients following cGMP standards and ACC SOP’s and interact with clients for questions related to their preliminary results
• Proper documentation of interactions with clients
• Check standardization of CSE for gel clot, turbidimetric, and chromogenic methods
• Review data for compliance with FDA Data Integrity
• Prioritize report review based on customer needs
• Detect and troubleshoot errors and inconsistencies in data during analysis
• Review instrument audit trails
• Initial and date each data page during review
• Sign reports as the Peer Reviewer responsible for review of the records
• Attend training as scheduled by ACC
• Other duties as assigned

Knowledge and Skill Requirements:

• Strong organizational skills
• Strong interpersonal skills
• Must be detail oriented and have a good understanding of or working knowledge of aseptic/laboratory technique
• Ability to work independently, as well as, with others in a fast-paced laboratory environment
• Excellent oral and written communication skills
• Working knowledge of cGMP, USP <85>/<161>, ISO 13485, and internal standard operating procedures and policies
• Other – Hepatitis B vaccination

Education and Experience:

• Bachelor’s Degree in Chemistry, Biochemistry, related scientific discipline plus 2-3 years of experience working in a laboratory, or an equivalent combination of experience and/or education required.

General Competencies:

• Works well with internal and external customers, promotes a positive image of the company, and strives to solve issues raised by customers
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Strives to understand contributing factors, works to resolve complex situations
• 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 sitting, occasionally standing and walking. Constantly use hands to finger, handle or feel. Frequently reach with hands or arms. Constantly reading, typing and writing. Need to lift 1-10 lb. 1-33% of the time. Carry 11-25 lb. 1-33% of the time. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

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

In your cover letter please answer the following:

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

Purpose: In this role, you will be responsible for the performance and lifecycle management of analytical methods including transfer, validation, and troubleshooting. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with current Good Manufacturing Practices, Associates of Cape Cod (ACC) Standard Operating Procedures, compliance guidelines of the FDA and other regulatory bodies, and approved license requirements. Analyst is technically independent and has mastered fundamental Quality Control (QC) concepts as well as some specialized technologies. Independently designs, executes, interprets and reports results. Independently coordinates activities and executes tasks in an efficient manner and collaborates with others both inside QC and outside the department. Understands and can articulate scientific / regulatory principles and guide future projects. Has considerable knowledge in a specific field or general knowledge across many areas of QC testing / Analytical Method Development / Validation / Technology Transfer. Displays initiative and technical commitment and independence for study design. Effectively communicates results of work by organizing and providing written and oral presentations. Performs complex studies and makes independent contributions to the development of new technologies. Provides guidance and training to other staff members and demonstrates willingness to assist others with problems.

Knowledge and Skill Requirements:

• Industry experience in analytical method development, validation, and transfer in support of commercialization activities for biologics and/or medical devices
• Experience with cGMP requirements and application within the Quality Control environment. Understanding of industry standards and best practices (e.g., FDA, ICH, USP, EP and JP) for Quality Control of biologics and/or medical devices
• Working knowledge of cGMP and quality system requirements
• 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/ 5+ years of experience, M.S. or Ph.D. degree in a relevant scientific discipline preferred.

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

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

Grow your career in life sciences on Cape Cod!

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

Knowledge and Skill Requirements:

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

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

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

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

Purpose: In this role, you will work in a multidisciplinary environment where Biology and Medicine meet Engineering, Chemistry and Manufacturing to support the development of new endotoxin and glucan detection products.

General Responsibilities:

The major responsibilities of this position will be to support the advancement of the company product development pipeline.

• 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
• Follow Design Control requirements and SOPs in a GMP environment
• 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
• Knowledge of basic statistics
• Experience with automation and automated processes
• Understanding of protein and enzyme function

Education and Experience:

• A BS/MS in biochemistry, chemistry, analytical chemistry, 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

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 here.

In your cover letter please answer the following:

• Have you completed the following level of education: BS/MS in biochemistry, chemistry, analytical chemistry, or closely 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: Biotech on Cape Cod! Seeking hardworking, motivated and reliable people for positions in our Manufacturing teams. Experience not necessary, we provide the training. Good attitude a must. 2pm-10:30pm AVAILABLE ONLY!

General Responsibilities:

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

Knowledge and Skill Requirements:

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

Education and Experience:

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

Job Type: Full-Time

To Apply:

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

In your cover letter please answer the following:

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

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

General Responsibilities:

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

Knowledge and Skill Requirements:

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

Education and Experience:

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

General Competencies:

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

Physical Requirements:

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

Job Type: Full-Time

To Apply:

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

In your cover letter please answer the following:

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

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: PhD in Chemistry, Biochemistry 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.