Senior QA Associate - Cell Therapy GMP Specialist (Onsite)

Lyell Immunopharma; Bothell (WA); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Equity Incentive Plan

Job summary

Lyell Immunopharma in Bothell, WA, is seeking a Quality Assurance Senior Associate to join the LyFE manufacturing facility onsite Sunday through Wednesday, 10 hours per day. You will perform batch-record reviews, COA issuance, material disposition, deviation investigations, CAPA and change control, and other QA tasks to sustain manufacturing quality in the cleanroom.

Ideal candidates hold a BS in biochemistry/related field with 4–6+ years in GMP biopharma, plus 2+ years in GMP quality, plus

Qualifications

• BS degree with 7+ years in a relevant field (e.g. biochemistry, chemical engineering, bioengineering, or related scientific field)
• 4-6+ years of experience in GMP biopharmaceutical operations with a minimum of 2+ years in GMP quality
• Experience with cellular therapy manufacturing and lentiviral vector manufacturing

Responsibilities

• Review and approve executed electronic batch records and resolve discrepancies with manufacturing personnel
• Review and approve test results and issue COAs as applicable in the LIMS
• Provide quality support for manufacturing operations in cleanroom facilities
• Be a quality contact for process support escalations, troubleshooting, triage and resolution
• Perform routine QA activities such as intake of patient apheresis and drug product pack-out
• Compile, review and approve lot disposition records
• Perform routine raw material disposition and approve material specifications
• Review and approve Deviation, Change Control, CAPA, Excursion and Nonconformance records
• Promote safety and GMP compliance; identify opportunities for continuous improvement
• Support Process/Method Qualification and Validation activities with quality review of protocols and data
• Perform internal audits as required; support operational excellence initiatives

Skills

Quality Assurance

cGMP

Communication

Project planning

Cross-functional collaboration

Education

BS degree in biochemistry/related field

Tools

eQMS

Job description

Lyell Immunopharma in Bothell, WA, is seeking a Quality Assurance Senior Associate to join the LyFE manufacturing facility onsite Sunday through Wednesday, 10 hours per day. You will perform batch-record reviews, COA issuance, material disposition, deviation investigations, CAPA and change control, and other QA tasks to sustain manufacturing quality in the cleanroom.

Ideal candidates hold a BS in biochemistry/related field with 4–6+ years in GMP biopharma, plus 2+ years in GMP quality, plus