Quality Control Specialist
Job Description
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: Quality Control Specialist
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
Description:
We are seeking a Quality Control Specialist to support routine cGMP testing for raw materials, drug substances, and finished products within a manufacturing environment. This role is ideal for someone with strong bioassay experience who thrives in a fast-paced, collaborative setting.
You will play a key role in executing analytical methods, supporting method transfers, maintaining quality records, and ensuring compliance with regulatory standards. This position also involves training team members and partnering cross-functionally with Manufacturing, Quality, and Development teams.
Key Responsibilities:
Basic Qualifications:
Preferred Qualifications:
Additional Information:
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly.
You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
Title: Quality Control Specialist
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: 6+ month contract (extension possible)
- Pay rate: $32 – $35/hour + 10% shift differential
- Job Location: Needham, MA
- Schedule: Monday – Friday, 2:00 PM – 10:00 PM (2nd Shift)
- Number of openings: 2
- Job#: bh18876
Description:
We are seeking a Quality Control Specialist to support routine cGMP testing for raw materials, drug substances, and finished products within a manufacturing environment. This role is ideal for someone with strong bioassay experience who thrives in a fast-paced, collaborative setting.
You will play a key role in executing analytical methods, supporting method transfers, maintaining quality records, and ensuring compliance with regulatory standards. This position also involves training team members and partnering cross-functionally with Manufacturing, Quality, and Development teams.
- Perform routine bioassay testing for raw materials, drug substances, and finished products
- Support method transfers and qualification activities in collaboration with development teams
- Troubleshoot assay performance, laboratory procedures, and equipment issues
- Analyze, trend, and review laboratory data
- Write and revise SOPs, protocols, and technical reports
- Own and manage quality records (investigations, change controls, CAPAs)
- Ensure compliance with cGMP standards and regulatory requirements
- Provide training and mentorship to laboratory personnel
- Serve as a subject matter expert (SME) for bioassay-related projects
- Support audits and continuous improvement initiatives
- Maintain a safe and compliant laboratory environment
- Bachelor’s degree in a STEM field
- Minimum of 5 years of experience in a cGMP laboratory environment
- Hands-on experience with:
- Mammalian cell culture
- Cell-based assays
- ELISA
- Protein analysis
- In vitro relative potency assays (IVRPE)
- Experience with method validation and qualification (cell-based or protein assays)
- Strong track record of Right First Time (RFT) execution
- Knowledge of aseptic techniques and standard lab instrumentation (pH meters, balances, pipettes)
- Experience working in biological safety cabinets
- Familiarity with equipment calibration and maintenance
- Working knowledge of FDA, EU, and ICH regulatory guidelines
- Experience training or mentoring team members
- Strong technical writing and documentation skills
- Ability to work effectively in a fast-paced, cross-functional environment
- This is a fully on-site position (no remote option)
- Candidates must be authorized to work in the U.S. without current or future sponsorship
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly.
You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
Meet Your Recruiter
Caroline Driscoll
Account Manager & Sr. Technical Recruiter
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