Senior Specialist, Quality Assurance
Core
Senior QA Specialist supporting startup, operational readiness, and steady-state manufacturing and analytical operations at the Foster City Manufacturing New Chess Facility (NCF), ensuring alignment with manufacturing, digital, quality control, and compliance priorities.
Role type
Senior individual contributor, site-based Quality Assurance Specialist
Builds
GMP-compliant biologics manufacturing and analytical operations
Domain
Biopharmaceuticals / GMP Manufacturing
Required skills
GMP/GLPs proficiency, Quality Risk Management, CAPA management, regulatory compliance (FDA/Health Canada), cross-functional collaboration, project management, statistical process control, analytical methods, materials management
Preferred skills
Six Sigma/DMAIC, HACCP/FMEA, training program development, mentoring
Technologies
Microsoft Office, GMP documentation systems
Responsibilities
Review and approve laboratory investigations (OOS/OOT/deviations) and CAPA; Apply Quality Risk Management principles; Write or suggest changes to controlled documents (SOPs, Specifications); Maintain GMP/GLPs programs; Review manufacturing and QC data; Conduct internal GMP audits and support regulatory inspections; Provide leadership and mentoring for Quality personnel; Lead or support Quality-related operational projects.
Seniority
Senior, hands-on IC