Senior Quality Assurance Associate

Quality Assurance Senior Associate (Onsite)
Key Responsibilities

• Execute day-to-day Quality Assurance tasks to support ongoing manufacturing
• Review and approve executed electronic batch record comments; resolve discrepancies with manufacturing personnel
• Review and approve executed test results; perform LIS review tasks to issue Certificates of Analysis (COAs) as applicable
• Provide quality support for manufacturing operations in the cleanroom
• Serve as a quality point of contact for process support escalations, troubleshooting, triage, and resolution
• Perform routine hands‑on QA activities (e.g., intake of incoming patient apheresis; drug product pack‑out activities)
• Compile, review, and approve lot disposition records
• Perform routine raw material disposition and approve raw material specifications
• Review and approve Deviation, Change Control, CAPA, Excursion, and Nonconformance deliverables (as applicable)
• Promote a culture of safety and GMP compliance
• Identify opportunities for continuous improvement
• Support process/method qualification and validation by providing quality review of protocols, data, and reports
• Perform internal audits; support operational excellence initiatives

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

• 4–6+ years GMP biopharmaceutical operations; minimum 2+ years in GMP quality
• Proficiency using multiple digital GMP platforms
• Familiarity with Cellular Therapy manufacturing
• Familiarity with Lentiviral Vector manufacturing

• Experience in clinical and cGMP manufacturing
• Experience with electronic quality management systems (e.g., deviations, CAPAs, change management)

• Ability to work independently and with a team to set goals, develop project plans, monitor progress, and report results
• Excellent communication, emotional intelligence, and interpersonal skills
• Motivated, organized critical thinker with strong cross‑collaboration and business communication skills
• Fast learner; adaptable; creative problem‑solving
• Ability to prioritize, meet deadlines, and balance competing demands; desire to work in a fast‑paced start‑up
• Excellent analytical skills and scientific/technical ability

Sunday through Wednesday shift; 10 hours per day; onsite at Lyell Manufacturing Facility (LyFE), Bothell, WA; no remote work option

Salary range: $75,000 to $95,000 per year; opportunity for annual bonus; eligible for Lyell’s Equity Incentive Plan