Sr. Quality Assurance Specialist
Gilead Sciences
4 months ago
On-site
San Francisco Bay Area
$136,340 - $176,440 USD yearly
Operations
Position Summary
- Provide quality oversight and hands-on ownership for GxP quality records for Corporate Engineering and Facilities (CEF) activities (facilities, utilities, equipment, instruments, engineering systems) in Foster City, CA.
- Ensure compliance with quality objectives, regulatory requirements, and cGMP; own deviation investigations, CAPAs, effectiveness checks, and related change controls to keep records complete, accurate, and inspection-ready.
Key Responsibilities
- Independently conduct, document, and close investigations (facilities, utilities, equipment, instrumentation, calibration, maintenance, engineering systems).
- Own deviation investigations; manage and track Deviation Reports (root cause analysis, impact assessment, due dates).
- Lead CAPAs and verify effectiveness checks.
- Initiate/author/support Change Control Records for facility/utility changes, equipment/instrument install/removal, BMS/EMS configuration/firmware updates, and CMMS asset/engineering integrations.
- Maintain quality tracking tools/databases; develop and present quality metrics and trending; escalate risks/issues.
- Facilitate cross-functional investigations; apply structured Root Cause Analysis.
- Develop/revise controlled documents (SOPs, specifications, work instructions, templates); perform document reviews and high-level quality reviews of technical data.
- Support regulatory inspections and internal/external audits; provide guidance on cGMP/FDA/EU/ICH.
- Support projects by owning GxP records (deviations, investigations, CAPAs, change controls) and coordinating SME inputs for compliant closure.
Qualifications
- Bachelor’s in technical/scientific discipline with 6+ years pharma/life-science experience, OR Master’s with 4+ years.
- OR Bachelor’s with 6+ years in a GMP-regulated environment, OR Master’s with 4+ years GMP.
Skills/Preferred
- cGMPs and QA system principles; biotech/pharmaceutical GxP facilities/utilities/equipment/instrumentation.
- Root Cause Analysis; Six Sigma/Lean tools; risk management (e.g., HACCP, FMEA).
- Audit/investigation and technical writing; strong communication.
- Microsoft Office and Bluebeam; familiarity with EDMS, CMMS, QMS (preferred).
- Experience reading facility drawings (P&IDs, floor plans); commissioning/validation knowledge.
- Preferred: experience using GxP electronic systems (EDMS, CMMS, QMS).
Compensation/Benefits (if applicable)
- Salary range: $136,340.00 - $176,440.00; may be eligible for discretionary bonus/stock incentives; paid time off and benefits including medical, dental, vision, and life insurance.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.
- Provide quality oversight and hands-on ownership for GxP quality records for Corporate Engineering and Facilities (CEF) activities (facilities, utilities, equipment, instruments, engineering systems) in Foster City, CA.
- Ensure compliance with quality objectives, regulatory requirements, and cGMP; own deviation investigations, CAPAs, effectiveness checks, and related change controls to keep records complete, accurate, and inspection-ready.
Key Responsibilities
- Independently conduct, document, and close investigations (facilities, utilities, equipment, instrumentation, calibration, maintenance, engineering systems).
- Own deviation investigations; manage and track Deviation Reports (root cause analysis, impact assessment, due dates).
- Lead CAPAs and verify effectiveness checks.
- Initiate/author/support Change Control Records for facility/utility changes, equipment/instrument install/removal, BMS/EMS configuration/firmware updates, and CMMS asset/engineering integrations.
- Maintain quality tracking tools/databases; develop and present quality metrics and trending; escalate risks/issues.
- Facilitate cross-functional investigations; apply structured Root Cause Analysis.
- Develop/revise controlled documents (SOPs, specifications, work instructions, templates); perform document reviews and high-level quality reviews of technical data.
- Support regulatory inspections and internal/external audits; provide guidance on cGMP/FDA/EU/ICH.
- Support projects by owning GxP records (deviations, investigations, CAPAs, change controls) and coordinating SME inputs for compliant closure.
Qualifications
- Bachelor’s in technical/scientific discipline with 6+ years pharma/life-science experience, OR Master’s with 4+ years.
- OR Bachelor’s with 6+ years in a GMP-regulated environment, OR Master’s with 4+ years GMP.
Skills/Preferred
- cGMPs and QA system principles; biotech/pharmaceutical GxP facilities/utilities/equipment/instrumentation.
- Root Cause Analysis; Six Sigma/Lean tools; risk management (e.g., HACCP, FMEA).
- Audit/investigation and technical writing; strong communication.
- Microsoft Office and Bluebeam; familiarity with EDMS, CMMS, QMS (preferred).
- Experience reading facility drawings (P&IDs, floor plans); commissioning/validation knowledge.
- Preferred: experience using GxP electronic systems (EDMS, CMMS, QMS).
Compensation/Benefits (if applicable)
- Salary range: $136,340.00 - $176,440.00; may be eligible for discretionary bonus/stock incentives; paid time off and benefits including medical, dental, vision, and life insurance.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.