Job Title: QC Analyst

Work Location: Middlesex County, Massachusetts

Summary:

The Quality Control (QC) Analyst supports the Quality organization by performing analytical, microbiological, and environmental testing to ensure the safety and quality of cell therapy products and manufacturing operations. The role includes hands-on execution of GMP testing to support development, donor screening, in-process control, product release, stability, raw material release, and environmental monitoring in accordance with Standard Operating Procedures (SOPs). The QC Analyst maintains a compliant laboratory environment through accurate documentation, adherence to data integrity principles, and continuous improvement of QC operations. Additional responsibilities include supporting assay and equipment qualification, revising procedures, and implementing quality improvements.

Responsibilities:

• Perform analytical and microbiological testing in support of development, donor screening, in-process control, product release, and raw-material release following SOPs and GMP requirements.
• Conduct environmental and personnel monitoring of controlled areas, including viable air, non-viable particulates, surface, and gowning monitoring.
• Perform environmental data entry, verification, and trend analysis to monitor cleanroom performance and identify potential contamination trends.
• Execute microbiological assays such as sterility, endotoxin (LAL), bioburden, growth-promotion, gram staining and conductivity/TOC testing.
• Perform analytical assays including but not limited to cell counts and flow-cytometry-based identity or purity testing.
• Responsible for sample management, including receipt, labeling, storage, tracking, and distribution, in compliance with GMP requirements and established laboratory procedures.
• Compile and verify test results to support generation of Certificates of Analysis (CoA) for in-process materials, intermediates, and drug product release.
• Participate in aseptic process simulation (media-fill) run; provide on-floor QC support during execution and perform subsequent media incubation, inspection, and documentation.
• Sample, test, and document raw-material results to support disposition.
• Coordinate external testing activities by preparing and shipping samples to qualified contract laboratories, tracking results and maintaining documentation.
• Prepare reagents, media, and solutions as needed; maintain inventory of consumables and ensure proper labeling and traceability.
• Support instrument calibration, maintenance, and qualification activities.
• Assist with deviation investigations, change controls, and CAPA implementation under direction of QC leadership.
• Contribute to the revision of SOPs and test methods to ensure clarity and compliance.
• Maintain cleanroom gowning qualification and aseptic technique proficiency.
• Ensure completeness, accuracy, and traceability of all test data included in CoA packages prior to QA review.
• Work a flexible schedule to support manufacturing operations, including occasional weekends, holidays, extended hours, or off-shift coverage as required.

Qualifications:

• Minimum 2-4 years relevant QC experience in a GMP-regulated and clean room environment.
• Demonstrated proficiency in analytical and microbiological testing, including flow cytometry, cell counting, endotoxin, sterility, and environmental monitoring.
• Requires Bachelor’s degree in a scientific discipline or equivalent combination of education and experience.

Published Category: Quality & Validation