QA Specialist III
Gilead Sciences · Foster City, CA
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
This QA Specialist III role oversees quality assurance for clinical small molecule drug substance and oral solid dosage manufacturing at Gilead Sciences' Foster City location. Responsibilities include reviewing manufacturing documentation, maintaining GMP-compliant records, supporting process improvements, and conducting investigations using risk-based approaches. The position requires 5+ years of GMP experience with a bachelor's degree, or 3+ years with a master's degree.
What they're looking for
- 5+ years GMP environment experience with bachelor's degree, OR 3+ years with master's degree
- Proficiency in Good Manufacturing Practices and QA principles
- Knowledge of FDA/EMEA standards and quality systems
- Root cause analysis, Six Sigma, and LEAN methodology experience
- Audit, investigation, and technical report writing skills
- Microsoft Office application proficiency
- Strong verbal and interpersonal communication abilities
What you'll be doing
- Oversee quality assurance for clinical drug substance and oral solid dosage pilot manufacturing
- Review and approve batch records, product release documentation, deviations, and investigations
- Maintain accurate and timely quality records per GMP and quality systems
- Lead process improvement projects and support root cause analysis investigations
- Support regulatory inspections and internal audits with preparation and documentation
Privacy & handoff
This role links to Gilead Sciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.