Senior Associate, Quality Assurance

Responsibilities

• Execute day-to-day Quality Assurance tasks to support ongoing manufacturing
• Review and approve electronic batch record comments and resolve discrepancies
• Review and approve executed test results and issue Certificates of Analysis (COAs)
• Provide quality support for manufacturing operations in cleanroom facilities
• Act as a quality point of contact for process support escalations and troubleshooting
• Perform routine hands-on QA activities including patient apheresis intake and drug product pack-out
• Compile, review, and approve lot disposition records
• Perform raw material disposition and approve specifications
• Review and approve Deviation, Change Control, CAPA, Excursion, and Nonconformance records
• Support process and method qualification and validation activities
• Perform internal audits and support operational excellence initiatives

Requirements

• Experience in clinical and cGMP manufacturing
• Experience with electronic quality management systems (e.g., deviations, CAPAs, change management)
• Ability to work a Sunday through Wednesday shift, 10 hours per day
• Must be able to work onsite in Bothell, WA

Preferred Qualifications

• BS degree in biochemistry, chemical engineering, bioengineering, or related scientific field
• 7+ years of experience in a relevant field
• 4-6+ years of experience in GMP biopharmaceutical operations
• 2+ years of experience in GMP quality
• Proficiency using multiple digital GMP platforms
• Familiarity with Cellular Therapy or Lentiviral Vector manufacturing

About the Company

Lyell is committed to building an open, diverse, and inclusive culture, focusing on high-performing teams that respectfully challenge each other to drive innovation.