Senior Quality Assurance Associate

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.