lyellimmunopharma
Senior Associate, Quality Assurance
At a Glance
- Location
- Bothell, Washington, United States
- Experience
- 7+ years
- Compensation
- ry range for this position is $75,000 to $95,000 per year, with the opportunit
- Posted
- 2026-06-17T18:57:13-04:00
Key Requirements
Certifications
- GMP
Domain Knowledge
- Clinical
- Engineering
- Manufacturing
- Medical
Requirements
Experience in clinical and cGMP manufacturing required.
Experience with electronic quality management systems (e.g.
deviations, CAPAs, change management) required.
4-6+ years of experience in GMP biopharmaceutical operations with a minimum of 2+ years in GMP quality
Proficiency using multiple digital GMP Platforms
Familiarity with Cellular Therapy manufacturing
Responsibilities
Execute the Day-to-Day Quality Assurance Tasks to Support Ongoing Manufacturing:
Review and approve executed electronic batch record comments and resolve discrepancies with manufacturing personnel.
Review and approve executed test results, perform review tasks in the laboratory information management system to issue Certificates of Analysis (COAs) as applicable.
Provide quality support for manufacturing operations in the cleanroom facilities
Be a quality point of contact for process support escalations, troubleshooting, triage and resolution.
Perform routine hands-on QA activities such as intake of incoming patient apheresis and drug product pack-out activities.