QC Associate Bioassay & Molecular Biology

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.