Senior Quality Assurance Associate
Lyell Immunopharma
August 19, 2026
On-site
Bothell, WA
Operations
Quality Assurance Senior Associate (LyFE) — Bothell, WA (Onsite)
Shift: Sunday–Wednesday, 10 hours/day.
Responsibilities:
- 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.
Preferred Education:
- BS degree with 7+ years in a relevant field (biochemistry, chemical engineering, bioengineering, or related).
Preferred Experience:
- 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.
Required Skills/Abilities:
- 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.
Compensation:
- $75,000–$95,000/year plus annual bonus opportunity; eligible for Equity Incentive Plan.
Shift: Sunday–Wednesday, 10 hours/day.
Responsibilities:
- 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.
Preferred Education:
- BS degree with 7+ years in a relevant field (biochemistry, chemical engineering, bioengineering, or related).
Preferred Experience:
- 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.
Required Skills/Abilities:
- 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.
Compensation:
- $75,000–$95,000/year plus annual bonus opportunity; eligible for Equity Incentive Plan.