Senior QA Associate — GMP Manufacturing (Onsite)

Lyell; Bothell (WA); On-site; USD 103,155,000 - 128,943,000; Full time

Benefits offered by this job

Equity Incentive Plan

Job summary

Lyell Manufacturing Facility in Bothell, WA seeks a Quality Assurance Senior Associate to perform batch record review, raw material disposition, deviation investigations, CAPA, and change control approvals onsite. The role follows a Sunday–Wednesday, 10-hour shift, with an annual bonus eligibility and Equity Incentive Plan participation.

Onsite only, with no remote option. The ideal candidate has 7+ years in GMP biopharma QA, hands-on experience with electronic QA systems, LIMS, and COA

Qualifications

• BS degree with 7+ years in a relevant field (e.g. biochemistry, chemical engineering, bioengineering)
• Experience in GMP biopharmaceutical operations and quality systems
• Proficiency with eQMS (deviations, CAPAs, change control) and LIMS

Responsibilities

• Review and approve electronic batch records and resolve discrepancies with manufacturing
• Review test results and issue Certificates of Analysis (COAs) as applicable
• Provide QA support for manufacturing operations in cleanroom environments
• Act as quality point of contact for process support escalations and investigations
• Perform intake of patient apheresis and drug product pack-out activities
• Compile and approve lot dispositions and raw material specifications
• Review and approve Deviation, Change Control, CAPA, and nonconformance deliverables
• Support process/method qualification and validation activities
• Conduct internal audits and support operational excellence initiatives
• Promote GMP compliance and a culture of safety

Skills

Quality Assurance

GxP

Deviations

CAPA

Change Control

Batch Review

COA Review

LIMS

Documentation

Problem Solving

Education

BS degree in biochemistry/chemical engineering/related

Tools

GMP software

Job description

Lyell Manufacturing Facility in Bothell, WA seeks a Quality Assurance Senior Associate to perform batch record review, raw material disposition, deviation investigations, CAPA, and change control approvals onsite. The role follows a Sunday–Wednesday, 10-hour shift, with an annual bonus eligibility and Equity Incentive Plan participation.

Onsite only, with no remote option. The ideal candidate has 7+ years in GMP biopharma QA, hands-on experience with electronic QA systems, LIMS, and COA