Quality Assurance Specialist - Biotechnology

Position:
Quality Control (QC) Specialist

Location:

Norwood, MA

Duration: 6+ Months Contract

The QC Specialist will support routine cGMP analytical testing of raw materials, drug substances, and finished products within a manufacturing environment and associated contract laboratories. This role requires strong hands‑on laboratory expertise and the ability to execute, troubleshoot, transfer, and qualify analytical and bioassay methods while maintaining full compliance with cGMP and regulatory requirements.

The individual will serve as a subject matter expert (SME) in bioassays, working closely with Manufacturing, Quality Assurance, and Development teams to ensure timely and accurate release testing, method performance, and continuous process improvement.

• Perform routine cGMP testing of raw materials, intermediates, and finished products.
• Execute and troubleshoot analytical and bioassay methods, including cell‑based and protein assays.
• Lead and support method transfers, validations, and qualification activities.
• Analyze, interpret, and trend analytical data to ensure accuracy and compliance.
• Author and revise SOPs, test methods, protocols, and technical reports.
• Manage quality systems documentation, including investigations, deviations, change controls, and CAPAs.
• Support audit readiness and regulatory inspections.
• Train and mentor junior analysts to ensure Right‑First‑Time execution.
• Collaborate cross‑functionally with Manufacturing, QA, and Development.
• Maintain laboratory safety and compliance standards.
• Contribute to continuous improvement initiatives and special projects.

• Bachelor’s degree in a STEM discipline (Biology, Biochemistry, Biotechnology, or related field).
• Minimum of 5 years of hands‑on experience in a cGMP laboratory environment.
• Strong experience with:
  • Mammalian cell culture
  • Cell‑based bioassays
  • ELISA
  • Protein characterization and analysis
• Experience in method validation and qualification of cell‑based and protein assays.
• Solid understanding of cGMP, regulatory compliance, and quality systems.
• Demonstrated ability to execute with a Right‑First‑Time mindset.
• Strong troubleshooting, documentation, and analytical skills.