Quality Control Specialist

Quality Control (QC) Specialist -- Norwood, MA (100% Onsite)

The Quality Control (QC) Specialist supports cGMP-compliant routine testing of raw materials, drug substances, and finished products within a manufacturing environment and affiliated contract organizations. This on-site role is responsible for executing and troubleshooting analytical and bioassay methods, leading method transfers and qualification activities, and ensuring compliance with cGMP and regulatory standards.

The QC Specialist serves as a bioassay subject matter expert and collaborates cross-functionally with Manufacturing, Quality Assurance, and Development teams. The role also supports routine testing, special projects, audit readiness, and continuous improvement initiatives.

• Perform routine cGMP testing of raw materials, drug substances, and finished products
• Execute and troubleshoot analytical and bioassay methods
• Lead method transfers, validation, and qualification activities
• Author and revise SOPs, protocols, test methods, and technical reports
• Review, analyze, and trend laboratory data
• Manage quality records including investigations, deviations, change controls, and CAPAs
• Support internal and external audit readiness activities
• Train and mentor junior analysts
• Maintain laboratory safety and compliance standards
• Drive Right-First-Time execution and continuous improvement initiatives

• BA/BS degree in a STEM field
• Minimum 5 years of hands‑on experience in a cGMP laboratory environment
• Strong experience with:
• Mammalian cell culture
• Cell‑based assays
• ELISA
• IVRPE

• Experience in method validation and qualification of cell‑based and protein assays
• Strong understanding of cGMP and regulatory compliance requirements
• Demonstrated Right‑First‑Time execution mindset
• Excellent documentation and cross‑functional collaboration skills