Senior Quality Assurance Associate

Quality Assurance Senior Associate (LyFE) — Bothell, WA (Onsite)

Shift: Sunday–Wednesday, 10 hours/day.

• Execute day-to-day Quality Assurance tasks to support manufacturing.
• Review/approve executed electronic batch record comments; resolve discrepancies with manufacturing.
• Review/approve executed test results; perform LIMS review tasks to issue Certificates of Analysis (COAs) as applicable.
• Provide quality support in cleanroom manufacturing operations.
• Serve as QA point of contact for process escalations, troubleshooting, triage, and resolution.
• Perform hands-on QA activities: intake of incoming patient apheresis and drug product pack-out.
• Compile/review/approve lot disposition records.
• Perform raw material disposition and approve raw material specifications.
• Review/approve Deviation, Change Control, CAPA, Excursion, and Nonconformance record deliverables as applicable.
• Promote safety and GMP compliance; identify continuous improvement opportunities.
• Support Process/Method Qualification and Validation via quality review of protocols, data, and reports.
• Perform internal audits as required; support operational excellence initiatives.

• BS degree with 7+ years in a relevant field (biochemistry, chemical engineering, bioengineering, or related).

• 4–6+ years in GMP biopharmaceutical operations, including 2+ years in GMP quality.
• Proficiency with multiple digital GMP platforms.
• Familiarity with cellular therapy manufacturing; lentiviral vector manufacturing.

• Experience with clinical and cGMP manufacturing.
• Experience with electronic quality management systems (deviations, CAPAs, change management).
• Strong communication, interpersonal skills, and cross-collaboration; critical thinking/problem-solving.
• Ability to prioritize, meet deadlines, and work in a fast-paced start-up environment.
• Excellent analytical skills.

$75,000–$95,000/year plus annual bonus opportunity; eligible for Equity Incentive Plan.