Careers

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:

  • 2 - 3 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:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with CTS Analyst in your subject line.

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?

Customer Service Representative

Knowledge and Skill Requirements:

  • Data entry skills
  • Excellent verbal communication skills
  • Self starter, highly motivated with the ability to multi task 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

Job Type: Full-time

To Apply:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with Customer Service Representative in your subject line.

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?

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?

Senior Software Engineer

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

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:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with Senior Software Engineer in your subject line.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor’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:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with Product Development Associate in your subject line.

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?

Research Associate

General Responsibilities:

  • To perform analytical methods, including PAGE and protein determinations and general laboratory work
  • To manufacture specific materials for the recombinant chromogenic reagent project
  • To prepare LAL formulations as needed and perform LAL tests/assays as part of Research projects
  • To perform other assays and procedures such as enzyme activity assays
  • To become proficient with new techniques as required
  • Write SOPs and reports and prepare other paperwork as necessary, especially as related to the Quality System
  • To obtain project management experience
  • Use of various laboratory equipment for routine analyses
  • Operation of laboratory equipment using appropriate software
  • Designing and carrying out experimental protocols.
  • Following SOPs in a GMP environment.
  • Maintain records in accordance with Quality Assurance Guidelines.
  • Preparation of Research Reports.
  • Ability to interpret results from lab tests.
  • Conduct performance and analysis evaluations of competitive products.
  • Maintain supplies inventory and order items when needed.
  • Proper operation, standardization & maintenance of lab equipment.

Knowledge and Skill Requirements:

  • Good base knowledge of chemistry, biochemistry and biology
  • Thorough training and significant experience in standard concepts, practices and procedures within the LAL field as well as general laboratory techniques
  • Ability to work with minimal supervision
  • Ability to effectively communicate with peers and management as necessary and function well as a team member

Education:

  • A BSc, BA, MSc or MA degree in chemistry, biology or biochemistry is required
  • 5 years experience in an appropriate GMP laboratory setting working as a team member
  • Good communication skills both written and oral

Job Type: Full-time

To Apply:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with Research Associate in your subject line.

In your cover letter please answer the following:

  • Have you completed the following level of education: BSc, BA, MSc or MA 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:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with Technical Services BET Specialist in your subject line.

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:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with BET Product Specialist in your subject line.

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:

ACC Employment Application (PDF)
Please submit a current resume and cover letter to acc.hr@acciusa.com with QC Analyst I in your subject line.

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.