Sr. Quality Assurance Specialist
Gilead Sciences
June 30, 2026
On-site
La Verne, CA
Operations
Responsibilities (Senior Quality Assurance Specialist):
- Manages, prioritizes, and participates in batch record review and release activities, including review of manufacturing, environmental monitoring, and quality control data for in-process and finished products; responsible for final release of manufactured products.
- Participates in introduction of new clinical/commercial products to the site.
- Participates in risk assessments.
- Authors, reviews, and approves changes to standard operating procedures, specifications, forms, and other controlled documents to ensure high-quality products and compliance with current GMPs.
- Participates in site inspection readiness activities.
- Participates in internal and external audits as needed.
- Participates in continuous improvement initiatives.
- Supports generation and review of metrics and trending data.
- Partners to ensure resolution of quality issues.
- Reviews/approves Deviations, CAPAs, and Change Management records as required.
- Works on moderately complex problems requiring in-depth evaluation and judgement for scientific routine recommendations.
- Performs activities to ensure compliance with applicable quality objectives and regulatory requirements.
Requirements:
- Bachelor’s + 6+ years OR Master’s + 4+ years OR PhD/PharmD + 0+ years.
- Experience with parenteral and aseptic operations; proficiency/familiarity with Annex 1.
- Experience across Quality Assurance and/or Quality Systems.
- Experience interacting with regulatory agencies.
- Excellent interpersonal, verbal, and written communication skills.
- Knowledge of Risk Management tools (e.g., HACCP, FMEA).
Preferred Qualifications:
- Advanced degree (Master’s or PhD/PharmD).
- Experience with batch record review and release of clinical and/or commercial products.
- Experience with medical devices; biological products.
Benefits/Compensation (as stated):
- Salary range: $123,930.00–$160,380.00; may be eligible for discretionary bonus/long-term incentives; paid time off; company-sponsored medical/dental/vision/life insurance.
Application Instructions:
- For current Gilead employees and contractors, apply via the Internal Career Opportunities portal in Workday.
- Manages, prioritizes, and participates in batch record review and release activities, including review of manufacturing, environmental monitoring, and quality control data for in-process and finished products; responsible for final release of manufactured products.
- Participates in introduction of new clinical/commercial products to the site.
- Participates in risk assessments.
- Authors, reviews, and approves changes to standard operating procedures, specifications, forms, and other controlled documents to ensure high-quality products and compliance with current GMPs.
- Participates in site inspection readiness activities.
- Participates in internal and external audits as needed.
- Participates in continuous improvement initiatives.
- Supports generation and review of metrics and trending data.
- Partners to ensure resolution of quality issues.
- Reviews/approves Deviations, CAPAs, and Change Management records as required.
- Works on moderately complex problems requiring in-depth evaluation and judgement for scientific routine recommendations.
- Performs activities to ensure compliance with applicable quality objectives and regulatory requirements.
Requirements:
- Bachelor’s + 6+ years OR Master’s + 4+ years OR PhD/PharmD + 0+ years.
- Experience with parenteral and aseptic operations; proficiency/familiarity with Annex 1.
- Experience across Quality Assurance and/or Quality Systems.
- Experience interacting with regulatory agencies.
- Excellent interpersonal, verbal, and written communication skills.
- Knowledge of Risk Management tools (e.g., HACCP, FMEA).
Preferred Qualifications:
- Advanced degree (Master’s or PhD/PharmD).
- Experience with batch record review and release of clinical and/or commercial products.
- Experience with medical devices; biological products.
Benefits/Compensation (as stated):
- Salary range: $123,930.00–$160,380.00; may be eligible for discretionary bonus/long-term incentives; paid time off; company-sponsored medical/dental/vision/life insurance.
Application Instructions:
- For current Gilead employees and contractors, apply via the Internal Career Opportunities portal in Workday.