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Compensation

Full Description

Job Title: Senior Associate, Quality Assurance Location: Bothell, WA (Onsite) Schedule: 4-day, 10-hour shifts (Wed–Sat or Sun–Wed) Summary: The Senior Associate, Quality Assurance is responsible for performing routine QA activities that support ongoing manufacturing operations at a clinical and commercial manufacturing facility. This onsite role provides direct QA oversight, batch record review, raw material disposition, and support for investigations, change controls, and continuous improvement efforts. Key Responsibilities • Review and approve executed electronic batch records, comments, and discrepancies. • Review test results and perform LIMS review steps to issue Certificates of Analysis (as applicable). • Provide QA support on the manufacturing floor, including cleanroom operations. • Act as a QA point of contact for escalations, troubleshooting, and process support. • Perform hands-on QA activities such as patient apheresis intake and drug product pack-out. • Compile, review, and approve lot disposition documentation. • Conduct raw material disposition and approve raw material specifications. • Review and approve Deviations, CAPAs, Change Controls, Excursions, and Nonconformance records. • Support process/method qualifications and validation activities through QA review of protocols, data, and reports. • Participate in internal audits and operational excellence initiatives. • Promote a strong culture of safety, compliance, and continuous improvement. Qualifications • BS degree in a relevant scientific field (biochemistry, bioengineering, chemical engineering, etc.) with 7+ years of industry experience. • 4–6+ years in GMP biopharmaceutical operations, including 2+ years in GMP Quality. • Experience with electronic quality management systems (deviations, CAPAs, change controls). • Experience in clinical and cGMP manufacturing environments. • Familiarity with cellular therapy and/or lentiviral vector manufacturing preferred. • Strong analytical, communication, and cross-functional collaboration skills. • Ability to prioritize, meet deadlines, and adapt in a fast-paced, start-up environment. • Proficiency with digital GMP platforms.