QA Specialist II
Gilead Sciences
August 14, 2026
On-site
San Francisco Bay Area
Operations
Specific Job Responsibilities:
- Supports 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 clinical 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, and timely (ALCOA) quality records in accordance with GMP and quality systems.
- Supports QA team members in daily operations (lot disposition) and team process improvement projects.
- Participates in departmental and cross-functional projects delivering assigned QA deliverables.
- Supports small to moderately complex process improvement projects.
- Executes basic root cause analysis and uses risk-based thinking to support investigations and quality events.
- Identifies data trends/anomalies and potential compliance risks; escalates appropriately.
- Leads revision of GMP documentation to support QA projects.
- Creates metrics and reports under supervision of senior QA team members.
- Supports regulatory inspections and internal audits (preparation, execution, observation response generation).
Knowledge / Required Skills:
- Working knowledge of cGMPs; quality assurance systems/methods/procedures.
- Knowledge of FDA/EMEA standards and quality systems.
- Basic knowledge of Six Sigma, LEAN, and root cause analysis tools.
- Verbal, written, and interpersonal communication skills.
- Proficiency in Microsoft Office.
Basic Qualifications:
- 4+ years relevant GMP-environment experience with a BS; OR 2+ years with an MS.
- Prior pharmaceutical industry experience preferred.
Application Instructions (Current Employees/Contractors):
- Please apply via the Internal Career Opportunities portal in Workday.
- Supports 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 clinical 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, and timely (ALCOA) quality records in accordance with GMP and quality systems.
- Supports QA team members in daily operations (lot disposition) and team process improvement projects.
- Participates in departmental and cross-functional projects delivering assigned QA deliverables.
- Supports small to moderately complex process improvement projects.
- Executes basic root cause analysis and uses risk-based thinking to support investigations and quality events.
- Identifies data trends/anomalies and potential compliance risks; escalates appropriately.
- Leads revision of GMP documentation to support QA projects.
- Creates metrics and reports under supervision of senior QA team members.
- Supports regulatory inspections and internal audits (preparation, execution, observation response generation).
Knowledge / Required Skills:
- Working knowledge of cGMPs; quality assurance systems/methods/procedures.
- Knowledge of FDA/EMEA standards and quality systems.
- Basic knowledge of Six Sigma, LEAN, and root cause analysis tools.
- Verbal, written, and interpersonal communication skills.
- Proficiency in Microsoft Office.
Basic Qualifications:
- 4+ years relevant GMP-environment experience with a BS; OR 2+ years with an MS.
- Prior pharmaceutical industry experience preferred.
Application Instructions (Current Employees/Contractors):
- Please apply via the Internal Career Opportunities portal in Workday.