Associate II, Quality Assurance
Lyell Immunopharma
June 25, 2026
On-site
Bothell, WA
Operations
Quality Assurance Associate II (Onsite)
Key Role and Responsibilities:
- Review and approve executed electronic batch records; resolve discrepancies with manufacturing personnel.
- Review and approve Deviation, Excursion and CAPA records.
- Provide quality support for cleanroom manufacturing operations (e.g., intake of patient apheresis material, product pack-out, event triage).
- Serve as a quality point of contact for process support escalations, troubleshooting, triage, and resolution.
- Review and disposition incoming raw materials; approve raw materials.
- Review and approve executed test results; use the laboratory information management system to issue Certificates of Analysis (COAs).
- Author and/or collaborate on SOP creation, revision, and obsolescence across the LyFE site.
- Review and approve asset induction/release deliverables, on-demand work, and non-conformances.
- Support routine Quality operations and represent Quality Assurance on project-specific teams.
- Promote safety and GMP compliance; identify continuous improvement opportunities.
Preferred Education:
- AA/BA or BSc degree (or equivalent combination of education and work experience).
Preferred Experience:
- 3+ years cGMP experience in GMP biopharmaceutical operations; prior GMP Quality role experience.
- Proficiency using multiple digital GMP platforms.
- Familiarity with cellular therapy and lentiviral vector manufacturing.
Knowledge, Skills and Abilities:
- Experience with electronic quality management systems (deviations, CAPAs, change management).
- Strong communication, interpersonal skills, and cross-collaboration.
- Independent and team-oriented; critical thinking, fast learning, adaptability, and analytical/scientific-technical skills.
Schedule/Location:
- Shift schedule: Sun–Wed or Wed–Sat; 10 hours/day; onsite in Bothell, WA (no remote option).
Compensation/Benefits:
- $36.00–$41.00 hourly; opportunity for annual bonus; eligible for Equity Incentive Plan.
Application Instructions:
- If interested and think you could fit, please apply.
Key Role and Responsibilities:
- Review and approve executed electronic batch records; resolve discrepancies with manufacturing personnel.
- Review and approve Deviation, Excursion and CAPA records.
- Provide quality support for cleanroom manufacturing operations (e.g., intake of patient apheresis material, product pack-out, event triage).
- Serve as a quality point of contact for process support escalations, troubleshooting, triage, and resolution.
- Review and disposition incoming raw materials; approve raw materials.
- Review and approve executed test results; use the laboratory information management system to issue Certificates of Analysis (COAs).
- Author and/or collaborate on SOP creation, revision, and obsolescence across the LyFE site.
- Review and approve asset induction/release deliverables, on-demand work, and non-conformances.
- Support routine Quality operations and represent Quality Assurance on project-specific teams.
- Promote safety and GMP compliance; identify continuous improvement opportunities.
Preferred Education:
- AA/BA or BSc degree (or equivalent combination of education and work experience).
Preferred Experience:
- 3+ years cGMP experience in GMP biopharmaceutical operations; prior GMP Quality role experience.
- Proficiency using multiple digital GMP platforms.
- Familiarity with cellular therapy and lentiviral vector manufacturing.
Knowledge, Skills and Abilities:
- Experience with electronic quality management systems (deviations, CAPAs, change management).
- Strong communication, interpersonal skills, and cross-collaboration.
- Independent and team-oriented; critical thinking, fast learning, adaptability, and analytical/scientific-technical skills.
Schedule/Location:
- Shift schedule: Sun–Wed or Wed–Sat; 10 hours/day; onsite in Bothell, WA (no remote option).
Compensation/Benefits:
- $36.00–$41.00 hourly; opportunity for annual bonus; eligible for Equity Incentive Plan.
Application Instructions:
- If interested and think you could fit, please apply.