About the job
The Quality Assurance Specialist III plays a critical role in ensuring the quality of analytical and microbiological testing within a dynamic, regulated environment of cell therapy manufacturing. This position is pivotal in adhering to current Good Manufacturing Practices (cGMP), regulatory requirements, internal quality protocols, and industry-leading practices. The Specialist acts as a primary liaison for Quality Assurance within both laboratories, delivering high-level review, technical evaluations, resolution of issues, and ongoing support for testing activities that uphold product quality, safeguard patient safety, and maintain data integrity.
Key Responsibilities:
- Oversee daily operations of the Analytical and Microbiology laboratories to guarantee compliance with cGMP, regulatory standards, and internal quality criteria.
- Examine and authorize laboratory data packages, including analytical raw data and microbiological test results, ensuring completeness, accuracy, and data integrity.
- Act as the QA reviewer for laboratory deviations, investigations of Out of Specification (OOS) and Out of Trend (OOT) results, environmental monitoring excursions, and other laboratory incidents.
- Evaluate and sanction change controls concerning laboratory methodologies, instrumentation, workflows, and controlled documents.
- Conduct routine GxP walkthroughs of laboratory spaces, identifying compliance deficiencies, documenting findings, and ensuring prompt resolution.
- Review and approve method validation protocols, equipment qualification documents, and relevant Standard Operating Procedures (SOPs).
- Represent QA during internal audits, regulatory inspections, and laboratory readiness assessments.
- Serve as the subject matter expert (SME) for analytical testing and microbiological methods related to cell therapy products.
- Manage the retrieval of QC samples from liquid nitrogen (LN2) and arrange for the storage of in-process control (IPC) samples.
- Support the training and mentoring of QC personnel on quality principles, documentation standards, and management of deviations/OOS/OOT/CAPA.
- Collaborate across various departments, including QC labs, Manufacturing, Quality Systems, ASAT, and Regulatory Affairs to facilitate effective sample testing and product release.
- Engage in continuous improvement initiatives to enhance data integrity, optimize workflows, and reinforce laboratory compliance.
- Contribute to risk assessments regarding laboratory operations, equipment, and method lifecycle activities.
- Review laboratory system entries, electronic data workflows, and system upgrades.

