Careers

Senior Research Scientist

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

General Responsibilities:

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

Knowledge and Skill Requirements:

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

Education and Experience:

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

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

  • Have you completed the following level of education: PhD in Chemistry, Biochemistry or related field or an equivalent combination of experience?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Quality Assurance Specialist

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

General Responsibilities:

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

Knowledge and Skill Requirements:

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

Education and Experience:

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

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor’s degree or equivalent experience?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Shipping/Receiving Clerk

Ensure that all customer orders and outgoing packages are delivered to customers according to IATA, DOT and GMP regulation in a timely manner. To act as back-up in the receiving department and assist in the receipt, transfer and storage of all incoming material and freight.

General Responsibilities:

  • Shipping:
    • Knowledgeable in utilizing a variety of shipping systems such as UPS, FedEx, etc.
    • Responsible for the correct packaging of materials to include appropriate content identification, classification and labeling.
    • Fulfillment of all Customers orders
    • Control of all “Finished Released” product
      • Assist in assembly of kits when needed
      • Assist in labeling department when needed
    Receiving Backup and assistant which includes;
    • Receives/stores all materials for ACC use and performs all necessary receiving transaction within Great Plains, confirms accuracy of receipt against ACC documentation-includes delivery of CTS and Beacon Diagnostics samples to the appropriate department.
    • Fulfills/transacts and delivers all in-house material requisitions
    • Cycle counting
    • Warehouse management
    Safety:
    • Adherence to ACC’s safety policy.
    • Responsible for hazard communication.
    • Knowledgeable in emergency response.

Knowledge and Skill Requirements:

  • Experience working within a ISO and GMP regulated environment
  • 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 50 lbs.
  • Working computer knowledge
  • Excellent data entry skills

Education and Experience:

  • Previous experience in Shipping and Receiving.
  • A minimum of a High School diploma or an equivalent combination of experience and/or education requirement.
  • IATA/DOT training preferred.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Shipping/Receiving Clerk 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?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Sr. Software Engineer

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

General Responsibilities:

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

Knowledge and Skill Requirements:

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

Nice To Have:

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

Education and Experience:

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

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's or equivalent?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Facilities Supervisor

In this role, you will supervise the day to day operation, maintenance and repair of the facility and equipment. This includes, but is not limited to the planning, budgeting and scheduling of all services as required.

General Responsibilities:

  • Oversee the maintenance and work order programs including:
  • Scheduling/coordinating services
  • Contractor oversight
  • Database management for accuracy and report trending
  • Documentation review * Oversee Building Management System (BMS) to ensure proper operation of equipment controlled and monitored.
  • Initiate, execute and approve Quality Processes Workflows (Quality Events, Change Controls, Deviations, Audit Findings, etc.)
  • Provide proper man hour utilization of Facilities technicians and outside vendors to ensure all PM's and WO's are completed as scheduled.
  • Develop new procedures and revise existing procedures to meet current work practices and quality requirements.
  • Affirm Equipment Maintenance Program SOP match existing practices and keep current.
  • Review and implement new work practices to gain efficiency while meeting quality requirements
  • Improve maintenance activities towards increasing equipment reliability * Assist with the planning and implementation of shutdown events.
  • Track and trend equipment performance for metrics reporting.
  • Supervise and support corporate compliance and regulatory audits and audit action items as they pertain to the facility and equipment.
  • Maintain records for regulatory compliance, building operations, repairs, parts and equipment.
  • Provide leadership and guidance to direct reports.
  • Assist with the development and control of the budget for the Facilities Department.
  • Maintain consistent communication with manager on key facility issues, potential issues and how they may be resolved.
  • Provide support for facility related activities varying in nature

Education and Experience:

Must have excellent mechanical skills related to steam, electrical, plumbing, controls, pneumatics, HVAC and building automation systems.· Ability to read and understand electrical, mechanical and P&ID schematics. Must have experience working within a maintenance management system and scheduling maintenance/work order activities. Must have experience in a supervisory role. · Must be available for on-call for emergencies. Must have a high level of accuracy and attention to detail. Like to have familiarity with regulations including cGMP and ISO 13485 or experience working within a regulated environment. A minimum of a Bachelor's Degree in a scientific or engineering field or an equivalent combination of experience and/or education required.

  • At least 5 years’ experience with equipment troubleshooting, repair and maintenance. Ideally this experience would be within in a cGMP manufacturing facility.
  • At least 3 years’ experience in a supervisory role

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's Degree in a scientific or engineering or equivalent?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Software Engineer

In this position, you will be responsible for the design and development of software to support the manufacture, sale and support of ACC’s endotoxin and glucan detection products and develop/maintain software to support company’s line of business.

General Responsibilities:

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

Knowledge and Skill Requirements:

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

Nice To Have:

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

Education and Experience:

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

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor of Science or equivalent?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Production Technician

General Responsibilities:

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

Knowledge and Skill Requirements:

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

Education and Experience:

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

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

  • Have you completed the following level of education: High School?
  • Are you authorized to work in the United States?

CTS  Analyst

General Responsibilities:

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

Knowledge and Skill Requirements:

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

Education and Experience:

  • Bachelor’s Degree in Chemistry, Biochemistry, a related scientific discipline, or an equivalent combination of experience and/or education required.

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor’s Degree?
  • Are you authorized to work in the United States?

Senior Calibration Technician

Knowledge and Skill Requirements:

  • Comprehensive knowledge of calibration concepts and associated regulations including NIST and ISO17025.
  • Thorough understanding of cGMP quality systems. Knowledge of ISO 13485 is preferred.
  • Demonstrated ability to write calibration procedures.
  • Proficient with computerized maintenance management systems, preferably Blue Mountain RAM.
  • Detail oriented and excellent organizational and customer service skills.
  • Equally comfortable working independently or in a group.
  • Ability to effectively communicate across departments as well as with contracted vendors.
  • A minimum of five years of calibration experience working in a regulated industry.

Education and Experience:

  • Minimum of an Associate’s degree in a technical discipline or an equivalent combination of experience and education required.
  • Previous experience in a regulated environment strongly desired.

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

  • Have you completed the following level of education: Associate’s degree or an equivalent?
  • Are you authorized to work in the United States?

Product Development Associate

General Responsibilities:

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

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

Education and Experience:

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

General Competencies:

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

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor of Science or equivalent?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Technical Services BET Specialist (2 openings)

General Responsibilities:

  • Provide technical support for endotoxin and glucan detection products.  This includes answering questions, troubleshooting for current ACC customers.
  • Knowledge of relevant instrumentation and softwares used for endotoxin and glucan detection by the end users
  • Troubleshoot/triage issues, problems and complaints in a timely manner, documenting them in CRM and providing trending to manager. Frequent follow up on all issues ensuring timely resolution of the customer’s issue.
  • As an outcome of triaging issues, determine if the issue is a complaint, write up an executive summary of the complaint, properly document in CRM and forward for documenting in QUMAS. Ensure continuity of follow ups and timely resolution of complaints.
  • Ability to effectively communicate and explain detailed and/or complicated technical issues in terms that benefit users and help resolve problems and issues.
  • Identify key technical issues to be addressed in client communications
  • Transmit information to customers in a clear and concise manner
  • Proper documentation of client interactions
  • Maintains Customer Database - monitor progress of potential customers’ product trials; follow up with customers regularly
  • Visit customers when necessary to troubleshoot problems
  • Participate in onsite or offsite workshops as needed
  • May be asked to deliver trainings/ presentations  during workshops
  • Documented proficiency with instrument calibrations and software validations.
  • Serve as a backup to perform instrument calibrations and validations.
  • Verifying in-service pipettes (as found) prior to their calibration.
  • Participate in laboratory testing, software evaluations and projects as needed.
  • Ability to travel (25% or more)
  • 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
  • Obtain further training in areas identified by Supervisor or Manager, Technical Services

Knowledge and Skill Requirements:

  • Excellent communication skills
  • Demonstrated ability to speak in public forums
  • Work well in team-based assignments
  • Work well under pressure in a dynamic environment
  • Knowledge of photometric instrumentation and photometric instrumentation-related softwares and instrumentation
  • Knowledge of Microsoft SQL database
  • Must have good laboratory skills, including pipetting and aseptic technique
  • Knowledge of BET regulations and guidances
  • Knowledge and ability to perform work in compliance with applicable cGMP and ISO regulatory requirements
  • Required to pass a pipetting proficiency training and certification course.

Education:

  • A minimum of a Bachelor of Science degree or an equivalent combination of experience and/or educational requirement.
  • Concentration in biochemistry, chemistry, or microbiology.
  • Experience with customer database, presentation software, BET testing instrumentation and software, Quality System controlled work environments, GMP/ISO regulated work.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Technical Services BET Specialist here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor of Science or equivalent?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

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

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

Knowledge and Skill Requirements:

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

Education:

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

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

  • Have you completed the following level of education: Master's Degree?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Quality Control Analyst I

Grow your career in life sciences on Cape Cod!

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

Knowledge and Skill Requirements:

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

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

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

  • How many years of Quality Control experience do you have?
  • Have you completed the following level of education: Bachelor's Degree?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Associates of Cape Cod, Inc. is an Equal Opportunity Employer.