QA Specialist III
Gilead Sciences
August 14, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Job Responsibilities:
- Provides direct QA oversight of clinical small molecule drug substance and oral solid dosage (OSD) pilot plant manufacturing, warehouse, and is responsible for product disposition using risk-based and phase-appropriate approach.
- Reviews and approves manufacturing documentation (batch records, product release documentation, deviations, investigations such as OOS/OOT/atypical, CAPAs, change controls, protocols, and reports).
- Maintains accurate, complete, timely (ALCOA) quality records in accordance with GMP and quality systems.
- Supports QA team members in daily operations (lot disposition) and process improvement projects.
- Participates in departmental and cross-functional projects, delivering assigned QA deliverables in compliance with quality systems.
- Supports small to moderately complex process improvement projects.
- Applies root cause analysis and risk-based thinking for investigations and quality events.
- Identifies data trends, anomalies, and potential compliance risks; escalates appropriately.
- Leads revisions of GMP documentation to support QA projects.
- Creates metrics and reports as needed.
- Supports regulatory inspections and internal audits (preparation, execution, observation response generation).
- Assists junior staff day-to-day as an SME.
- Authors/reviews SOPs, protocols, reports, and other GMP documentation.
Knowledge / Skills:
- Proficiency in GMP; QA principles, concepts, industry practices, and standards.
- Thorough knowledge of FDA/EMEA standards and quality systems; interfaces with manufacturing, distribution, and maintenance.
- Basic understanding of Six Sigma, LEAN, and root cause analysis tools.
- Audit and investigation skills; report writing; strong verbal, technical writing, and interpersonal skills.
- Proficient in Microsoft Office.
Basic Qualifications:
- 5+ years relevant experience in a GMP environment related field and a BS/BA.
OR
- 3+ years relevant experience and an MS.
- Prior pharmaceutical industry experience preferred.
Benefits:
- May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package (medical, dental, vision, life insurance).
Application instructions:
- Please apply via the Internal Career Opportunities portal in Workday.
- Provides direct QA oversight of clinical small molecule drug substance and oral solid dosage (OSD) pilot plant manufacturing, warehouse, and is responsible for product disposition using risk-based and phase-appropriate approach.
- Reviews and approves manufacturing documentation (batch records, product release documentation, deviations, investigations such as OOS/OOT/atypical, CAPAs, change controls, protocols, and reports).
- Maintains accurate, complete, timely (ALCOA) quality records in accordance with GMP and quality systems.
- Supports QA team members in daily operations (lot disposition) and process improvement projects.
- Participates in departmental and cross-functional projects, delivering assigned QA deliverables in compliance with quality systems.
- Supports small to moderately complex process improvement projects.
- Applies root cause analysis and risk-based thinking for investigations and quality events.
- Identifies data trends, anomalies, and potential compliance risks; escalates appropriately.
- Leads revisions of GMP documentation to support QA projects.
- Creates metrics and reports as needed.
- Supports regulatory inspections and internal audits (preparation, execution, observation response generation).
- Assists junior staff day-to-day as an SME.
- Authors/reviews SOPs, protocols, reports, and other GMP documentation.
Knowledge / Skills:
- Proficiency in GMP; QA principles, concepts, industry practices, and standards.
- Thorough knowledge of FDA/EMEA standards and quality systems; interfaces with manufacturing, distribution, and maintenance.
- Basic understanding of Six Sigma, LEAN, and root cause analysis tools.
- Audit and investigation skills; report writing; strong verbal, technical writing, and interpersonal skills.
- Proficient in Microsoft Office.
Basic Qualifications:
- 5+ years relevant experience in a GMP environment related field and a BS/BA.
OR
- 3+ years relevant experience and an MS.
- Prior pharmaceutical industry experience preferred.
Benefits:
- May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package (medical, dental, vision, life insurance).
Application instructions:
- Please apply via the Internal Career Opportunities portal in Workday.