Senior QA Specialist - QC Lab Operations

Bachelor’s degree in Life Sciences, Microbiology, Chemistry, Biotechnology, or a related scientific field required. · Advanced degree (MS) preferred but not required

Minimum of 5 years of QA or QC experience in a regulated biopharmaceutical, cell therapy, biologics, or sterile manufacturing environment. ·

Demonstrated familiarity with analytical methods (e.g., flow cytometry, qPCR, ELISA) and microbiological techniques (e.g., sterility, endotoxin, bioburden, mycoplasma, EM).

Prior experience reviewing laboratory data under cGMP required.

Experience supporting or leading laboratory investigations (deviations, OOS, OOT, EM excursions)

Strong working knowledge of cGMP, 21 CFR Parts 210/211, Part 1271, ICH guidelines, and data integrity (ALCOA+) principles.

The Quality Assurance Specialist III supports Quality oversight of the Analytical and Microbiology Laboratories within a fast-paced, regulated cell therapy manufacturing environment. This role ensures compliance with cGMP, regulatory expectations, internal quality standards, and industry best practices. The Specialist serves as a key QA liaison to both labs, providing elevated level review, technical assessment, issue resolution, and continuous improvement support for testing activities that ensure product quality, patient safety, and data integrity.

Provide Quality Assurance oversight of daily operations within the Analytical and Microbiology laboratories to ensure full compliance with cGMP, regulatory expectations, and internal quality standards.

Review and approve laboratory data packages, including analytical raw data, microbiological test results, environmental monitoring results, and associated documentation for completeness, accuracy, and data integrity (including audit trail review).

Serve as QA reviewer for analytical and microbiology-related deviations, OOS/OOT investigations, EM excursions, and other laboratory events.

Assess and approve change controls relating to laboratory methods, instrumentation, workflows, and controlled documents.