Principal Quality Assurance Validation Specialist
Core
Validates and qualifies laboratory and analytical equipment in a highly automated biologics manufacturing facility to ensure regulatory compliance.
Role type
Principal Quality Assurance Validation Specialist
Builds
Qualified laboratory and analytical equipment for drug substance manufacturing
Domain
Biologics manufacturing / Pharmaceutical Quality Assurance
Required skills
Validation protocol generation and execution, GMP environment experience, laboratory instrumentation expertise, deviation investigation, change control management, project management, team leadership
Preferred skills
People leadership/supervisory experience, experience with HPLC/GC/spectrophotometers, experience with manufacturing equipment validation
Technologies
HPLC, GC, balances, spectrophotometers, incubators
Responsibilities
Generate and review validation protocols and reports, analyze test results against criteria, troubleshoot laboratory equipment issues, approve deviation notifications and investigations, review and approve change controls and SOPs, coordinate with external vendors, train and mentor teammates, manage projects and status reports
Seniority
Principal, hands-on IC with potential for direct reports