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
QA Validation Specialist (IC)
Builds
Qualified and validated laboratory equipment and analytical systems for drug substance manufacturing
Domain
Biologics manufacturing / Pharmaceutical Quality Assurance
Required skills
Validation protocol generation and execution, GMP environment experience, laboratory instrumentation operation (HPLC, GC, balances, spectrophotometers), deviation investigation, change control management, SOP review, project management
Preferred skills
Experience with highly automated, digitally integrated environments, experience with manufacturing equipment and utilities validation
Technologies
HPLC, GC, balances, spectrophotometers, incubators
Responsibilities
Generate and review validation protocols and reports, analyze testing results against criteria, troubleshoot laboratory equipment issues, approve deviation notifications and investigations, review and approve change controls and SOPs, coordinate with Quality Control and vendors, train and mentor teammates
Seniority
Mid-level IC (4+ years experience)
