Senior QA Specialist – GMP Compliance & Batch Release

Regulatory Jobs; La Verne (CA); Vor Ort; USD 124.000 - 160.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Stock-based incentives

Paid time off

Medical/dental/vision and life ins.

Zusammenfassung

Gilead Sciences Inc. is seeking a Senior Quality Assurance Specialist to lead batch record review, release activities, and QA processes across clinical and commercial products. The role requires collaboration with regulatory bodies and internal partners to uphold GMP and quality standards.

The position involves risk assessments, SOP updates, audits, and continuous improvement initiatives within a dynamic pharmaceutical environment in the United States.

Qualifikationen

• Bachelor's degree + 6+ years of experience required
• Master's degree + 4+ years of experience required
• PhD or PharmD with 0+ years of experience
• Experience with parenteral and aseptic operations; familiarity with Annex 1 requirements
• Experience across broad areas of Quality Assurance and/or Quality Systems
• Experience with interacting with regulatory agencies
• Excellent interpersonal, verbal, and written communication skills
• Knowledge of Risk Management tools (e.g., HACCP and FMEA)

Aufgaben

• Manages, prioritizes, and participates in batch record review and release activities.
• Participates in introduction of new clinical/commercial products to the site.
• Participates in risk assessments.
• Participates in author, review, and approval of changes to SOPs, specifications, forms, and other controlled documents.
• Participates in site inspection readiness activities.
• Participates in internal and external audits as needed.
• Supports generation, and review of metrics and trending data.
• Partner with internal partners to ensure resolution of quality issues.
• Participates in review/approval of Deviations, CAPAs, and Change Management records.

Kenntnisse

Batch record review

GMP compliance

Regulatory interactions

Risk assessment

Communication skills

Ausbildung

Bachelor's Degree

Master's Degree

PhD or PharmD

Tools

Aseptic operations

Annex 1 familiarity

Jobbeschreibung

Gilead Sciences Inc. is seeking a Senior Quality Assurance Specialist to lead batch record review, release activities, and QA processes across clinical and commercial products. The role requires collaboration with regulatory bodies and internal partners to uphold GMP and quality standards.

The position involves risk assessments, SOP updates, audits, and continuous improvement initiatives within a dynamic pharmaceutical environment in the United States.