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Job description
Title: QC Associate Bioassay & Molecular Biology
Employment Type: Contract
Status: Accepting Candidates
About the Role
Support cGMP quality control testing of raw materials, drug substances, and finished products in a regulated laboratory environment. The role focuses on molecular biology, cell-based assays, and protein analysis while supporting method qualification and laboratory compliance.
Key Responsibilities
Execute QC molecular biology and bioassay methods, including mammalian cell-based potency assays, qPCR, sequencing, ELISA, and protein analysis.
Troubleshoot analytical methods, equipment, and assay performance; support method transfers and qualification activities.
Perform laboratory support activities including reagent preparation, equipment maintenance, logbook review, and aseptic laboratory practices.
Prepare and maintain SOPs, protocols, reports, and quality records while ensuring cGMP documentation and regulatory compliance.
Support investigations, change controls, CAPAs, audits, training, and continuous improvement initiatives.
Qualifications
BA/BS degree in a STEM discipline with 3-5 years of experience in a cGMP laboratory environment.
Hands-on experience with mammalian cell culture, cell-based and potency assays, molecular biology, ELISA, and protein analysis.
Experience with aseptic techniques, biological safety cabinets, reagent preparation, and small-volume pipetting.
Familiarity with laboratory equipment calibration and maintenance and analytical method development or qualification.
Working knowledge of relevant FDA, EU, and ICH guidelines, with the ability to work effectively in a fast-paced, cross-functional environment.
Compensation:
$30-$40/hr, based on experience and level.
Final compensation within the posted range will depend on qualifications, experience, and interview results.
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Worksite address
norwood, MA, 02062, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.