gilead
QA Specialist II
At a Glance
- Location
- United States - California - Foster City, United States
- Work Regime
- hybrid
- Employment
- Full time
- Experience
- 4+ years
- Compensation
- y range for this position is: $102,085.00 - $132,110.00. Gilead considers a variety o
- Posted
- 2026-08-14
Key Requirements
Certifications
- GMP
Domain Knowledge
- Insurance
- Medical
- Pharmaceutical
Benefits & Perks
aid time off, and a benefits package. Benefits include company-sponsored med
Requirements
4+ years of relevant experience in a GMP environment related field and a BS.
Prior experience in pharmaceutical industry is preferred.
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 utilizing risk-based and clinical phase appropriate approach.
Reviews and approves manufacturing documentation which may include batch records, product release documentation, deviations, investigations (i.e.
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 such as lot disposition and team process improvement projects.
Participates in departmental and cross-functional projects, delivering assigned QA deliverables in compliance with quality systems.