Senior QA Associate, GMP Biopharma — Onsite (Bothell)

Lyell Immunopharma; Bothell (WA); On-site; USD 50,000 - 62,000; Full time

Benefits offered by this job

Annual bonus

Equity Incentive Plan

Job summary

Lyell Immunopharma is seeking a Quality Assurance Senior Associate to join the LyFE manufacturing facility in Bothell, WA. The role covers batch record review, raw material disposition, deviation investigations, CAPA, change control, and other QA operations.

The position requires onsite work Sunday through Wednesday, 10 hours per day. The salary ranges from $36.00 to $45.00 hourly with potential annual bonus and equity incentives.

Qualifications

• 7+ years of experience in GMP biopharmaceutical operations or related field.
• Experience with electronic quality management systems (deviations, CAPAs, change management).
• Familiarity with batch record review and COA generation is preferred.

Responsibilities

• Execute day-to-day QA tasks to support ongoing manufacturing.
• Review and approve batch record comments and resolve discrepancies with manufacturing personnel.
• Review and approve test results and issue COAs as applicable in LIMS.
• Provide quality support for manufacturing operations in the cleanroom.
• Act as QA point of contact for process escalations and investigations.
• Review and approve lot dispositions and raw material specifications.
• Perform internal QA activities including deviation, CAPA, change control, and nonconformance reviews.
• Support process/method qualifications and validation activities.

Skills

GMP biopharma experience

Electronic quality management systems

Batch record review

Quality coordination & crossfunctional

Education

BS degree in biochemistry/chemical engineering/related field

Tools

eQMS platforms

Job description

Lyell Immunopharma is seeking a Quality Assurance Senior Associate to join the LyFE manufacturing facility in Bothell, WA. The role covers batch record review, raw material disposition, deviation investigations, CAPA, change control, and other QA operations.

The position requires onsite work Sunday through Wednesday, 10 hours per day. The salary ranges from $36.00 to $45.00 hourly with potential annual bonus and equity incentives.