Title: QC Associate - Bioassays & Molecular Biology (cGMP)
Location: Greater Norwood Area, MA (On-Site)
Employment Type: 6+ Months Contract (possible extension or conversion)
Status: Accepting Candidates
No. of position: 2 (Level I: (0-2 Years' Experience) Level II: (3-5 Years' Experience))
About the role
Support cGMP QC testing for raw materials, drug substances, and finished products across manufacturing facilities and affiliated contract organizations. Execute and troubleshoot critical analytical methods while driving compliance with regulatory and quality standards.
Key Responsibilities
- Execute QC methods including mammalian cell-based potency assays , qPCR , sequencing , and protein analysis .
- Perform general laboratory operations, including aseptic reagent preparation , equipment maintenance, and logbook reviews.
- Assist in troubleshooting analytical equipment and assay-related issues within a biosafety environment.
- Write, revise, and maintain SOPs , protocols, reports, and related cGMP documentation.
- Assist in the execution of quality records, including deviations/investigations , change controls , and CAPAs .
- Support internal/external audits and collaborate on continuous quality improvement initiatives.
Qualifications
- Hands-on experience in a cGMP laboratory setting executing mammalian cell culture , cell-based potency assays , ELISA , and molecular biology .
- Proficiency in aseptic techniques , micro-pipetting, and operating within a Biological Safety Cabinet (BSC) .
- Experience with laboratory instrumentation calibration, maintenance, and reagent preparation.
- Familiarity with FDA, EU, and ICH regulations and quality guidelines.
Compensation (MA Pay Transparency)
- Estimated hourly range: $30.00-$40.00/hr (W-2).
- Final rate within this range will be based on skills, experience, and interview results
QC Associate – Bioassays & Molecular Biology (cGMP) in norwood at Unknown Company
This position is listed as contract and onsite.