Job Title: Quality Control (QC) Specialist – Bioassays
Type: 6+ Month Contract
Shift: Second Shift, 2:00-10:00
Location: Norwood, MA - Fully Onsite
Job Summary
The Quality Control (QC) Specialist supports cGMP Quality Control testing for raw materials, drug substance, and finished drug products at a manufacturing site and affiliated contract organizations. This role is responsible for executing and troubleshooting analytical and bioassay methods, supporting method transfers and assay qualifications, and ensuring compliance with cGMP and regulatory requirements. The QC Specialist serves as a Bioassay Subject Matter Expert (SME), provides technical training, and collaborates cross-functionally with Manufacturing, Quality Assurance, and Development teams. This is a full-time, on-site position.
Key Responsibilities
Perform routine QC bioassay testing for raw materials, drug substance, and drug product
Execute and troubleshoot cell-based bioassays, ELISA, and protein analysis assays
Analyze, trend, and review laboratory data to ensure accuracy, completeness, and compliance
Ensure Right First Time (RFT) execution and adherence to cGMP standards
Maintain a safe, compliant laboratory environment
Collaborate with Development teams on method transfers and assay qualifications
Lead or support method validation and qualification activities
Serve as Bioassay SME and support special projects and continuous improvement initiatives
Troubleshoot assay performance, laboratory processes, and equipment-related issues
Own and manage quality records, including deviations, investigations, change controls, CAPAs, and events
Ensure compliance with cGMP documentation practices and regulatory expectations
Support internal and external audits and inspections
Complete required GMP training and assigned quality system tasks
Train and mentor QC analysts through on-the-job instruction
Author, revise, and review SOPs, protocols, reports, and technical documentation
Act as a cross-functional liaison between QC, QA, Manufacturing, and Development teams
Qualifications:
Technical Skills
Regulatory and Professional Skills
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