Sr. Quality Assurance Specialist

Role Summary

The Sr. Quality Assurance Specialist will join the Corporate Engineering and Facilities (CEF) team in Foster City, CA. This role provides quality oversight and hands-on ownership for GxP quality records related to facilities, utilities, equipment, instruments, and engineering systems. The incumbent ensures compliance with applicable quality objectives and regulatory requirements, including cGMP, and serves as the primary owner for deviation investigations, CAPAs, and change controls; and supports lifecycle management of impacted systems and activities.

Responsibilities

• Quality System Records (Core Scope)
  • Independently conduct, document, and close critical, major, and minor investigations related to facilities, utilities, equipment, instrumentation, calibration, maintenance, and engineering systems.
  • Act as the Deviation Investigation Owner for Facilities and Engineering quality records.
  • Manage and track Deviation Reports, ensuring timely root cause analysis, impact assessments, and adherence to established due dates.
  • Lead, assess, approve, and verify Corrective and Preventive Actions (CAPAs) and associated Effectiveness Checks.
  • Coordinate with Quality Assurance to ensure appropriate review, approval, and closure of quality records.
  • Initiate, author, and support Change Control Records associated with:
    • Facility modifications and utility system changes
    • Equipment and instrument installation or removal
    • BMS/EMS configuration and firmware updates
    • CMMS asset updates and engineering system integrations
  • Maintain and update quality tracking tools and databases; issue reminders and monitor performance against targets.
  • Develop, analyze, and present quality system metrics and trending reports for management review; escalate risks and issues as appropriate.
  • Demonstrated technical writing experience in biotech or pharmaceutical environments.
  • Proven technical literacy sufficient to understand facilities, utilities, MEP, and automation systems in support of GxP quality records.
• Investigation Leadership & Technical Problem Solving
  • Facilitate cross-functional meetings with Facilities Operations, Engineering, EHS, Calibration/PM, Automation, Validation, and external vendors to align on investigations and corrective actions.
  • Apply structured Root Cause Analysis (RCA) methodologies to identify underlying causes and define sustainable preventive actions.
  • Lead investigations ranging from moderately complex to highly complex, including:
    • Single-system issues
    • Multi-system or cross-functional CEF events (e.g., system configuration changes, automation interfaces, data trending, and activities spanning multiple CEF disciplines)
  • Provide technical input on engineering and maintenance issues, utility performance, asset reliability, and system configuration integrity.
• Documentation & Quality Oversight
  • Develop, write, revise, and implement controlled documents (SOPs, specifications, work instructions, templates) supporting Facilities Operations and Engineering.
  • Review documentation for accuracy, regulatory compliance, and alignment with operational intent.
  • Perform high-level quality reviews of technical data prior to senior management approval.
  • Maintain programs and processes that ensure ongoing compliance with cGMPs and internal quality standards.
  • Ensure quality records are clear, concise, complete, and inspection-ready.
• Compliance, Audits & Inspection Support
  • Support regulatory inspections and serve as an SME for Facilities, Utilities, Equipment, and Engineering Systems.
  • Support internal and external audits, including preparation of documentation and written responses.
  • Provide interpretation and guidance on cGMP, FDA, EU, and ICH regulations applicable to facilities and engineering systems.
  • Maintain current knowledge of compliance requirements through training and participation in industry forums.
• Operational & Project Responsibilities
  • Identify gaps or inefficiencies in existing processes and collaborate with peers and leadership to implement improvements.
  • Exercise sound judgment within established practices to select appropriate methods and evaluation criteria.
  • Manage multiple priorities simultaneously while maintaining high-quality output.
  • Support projects and quality events by owning and driving associated GxP quality records (deviations, investigations, CAPAs, change controls).
  • Coordinate and integrate inputs from subject matter experts to support timely and compliant record closure.
• Management & Cross-Functional Leadership
  • Provide coordination and work direction as needed (e.g., aligning SMEs on inputs, timelines, and deliverables for GxP quality records) without formal people-management responsibility.
  • Lead smaller, tactical initiatives related to quality records or process improvements within the department.
  • Serve as the CEF Quality point of contact on cross-functional initiatives in close partnership with the Quality organization.
  • Function as the primary Quality liaison for Facilities and Engineering operations.

Qualifications

• Required: Bachelor’s degree in a technical or scientific discipline with 6+ years of direct experience in the pharmaceutical or life-science industry, OR Master’s degree with 4+ years of direct industry experience.
• Required: OR Bachelor’s degree with 6+ years of experience in a GMP-regulated environment, OR Master’s degree with 4+ years of GMP-regulated experience.
• Preferred: Experience using GxP electronic systems, including EDMS, CMMS, and QMS platforms.

Skills

• Strong proficiency in cGMPs and Quality Assurance system principles, concepts, and industry best practices.
• Solid working knowledge of biotech/pharmaceutical facilities, utilities, equipment, and instrumentation in regulated GxP environments.
• Proficiency in Root Cause Analysis, Six Sigma/Lean tools, and risk management methodologies (e.g., HACCP, FMEA).
• Strong audit, investigation, and technical writing skills.
• Excellent communication, interpersonal, and organizational skills, with the ability to explain complex concepts clearly.
• Proficiency in Microsoft Office and Bluebeam; familiarity with EDMS, CMMS, QMS, and other GxP systems preferred.
• Ability to work under tight deadlines and manage competing priorities.
• Experience reading and interpreting facility drawings (P&IDs, floor plans).
• Working knowledge of commissioning and validation activities.

Education

• Bachelor’s degree in a technical or scientific discipline.
• Master’s degree in a technical or scientific discipline (preferred).