QA Specialist II — GMP & Compliance Champion

Regulatory Jobs; Foster City (CA); On-site; USD 102,000 - 132,000; Full time

Benefits offered by this job

Medical, dental, vision, and life保险

Discretionary annual bonus

Stock-based long-term incentives

Job summary

Gilead Sciences Inc. in Foster City, CA is seeking a QA professional to oversee clinical small molecule drug substance and OSD manufacturing. You will review batch records, deviations, investigations, and ensure ALCOA-compliant quality records.

You will support QA daily operations, lead QA projects, contribute to CAPAs, and assist in regulatory inspections and internal audits. A BS or MS in a relevant field is required along with GMP experience.

Qualifications

• 4+ years of relevant experience in a GMP environment and a BS.
• Or 2+ years of experience with an MS.
• Pharmaceutical industry experience preferred.

Responsibilities

• Supports QA oversight of clinical small molecule drug substance and OSD pilot plant manufacturing, warehouse, and product disposition.
• Reviews and approves manufacturing documentation including batch records, deviations, investigations, CAPAs, and change controls.
• Maintains ALCOA quality records in compliance with GMP and quality systems.
• Supports QA team in daily operations such as lot disposition and process improvement projects.
• Participates in cross-functional projects delivering QA deliverables in quality systems.

Skills

GMP knowledge

Quality assurance

Documentation control

Problem solving

MS Office

Education

BS in relevant field

MS in related field

Tools

Quality management software

Microsoft Office

Job description

Gilead Sciences Inc. in Foster City, CA is seeking a QA professional to oversee clinical small molecule drug substance and OSD manufacturing. You will review batch records, deviations, investigations, and ensure ALCOA-compliant quality records.

You will support QA daily operations, lead QA projects, contribute to CAPAs, and assist in regulatory inspections and internal audits. A BS or MS in a relevant field is required along with GMP experience.