Senior Scientist, QC Compliance
Core
Subject matter expert leading and authoring QC deviations, laboratory investigations, CAPAs, and change controls, while representing the department in internal/external inspections.
Role type
Senior Scientist, QC Compliance
Builds
Compliant quality management systems and regulatory responses
Domain
Biopharmaceuticals / Quality Control
Required skills
Root cause analysis, regulatory compliance (cGMP), technical writing, KPI generation, CAPA effectiveness analysis, change management, mentoring
Preferred skills
Analytical testing, microbiological testing, laboratory operations
Technologies
Quality management systems
Responsibilities
Lead and author QC deviations, laboratory investigations, CAPAs, and change controls; Conduct root cause analysis on non-routine complex investigations; Generate and report KPIs and analyze CAPA effectiveness; Represent department in internal/external inspections; Train and mentor others on deviation and investigation processes
Seniority
Senior, hands-on IC