QA Associate - Eurofins BioPharma Product Testing Toronto, Inc.
Core
Provide documentation and technical support for designated clients, ensuring product quality and GMP compliance.
Role type
Quality Assurance Associate (GMP)
Builds
Product release documentation, stability reports, deviation/CAPA records, and compliance documentation for pharmaceuticals, natural health products, and medical devices.
Domain
Life Sciences / Biopharma / GMP Compliance
Deliverable
Dashboards & analysis
Required skills
GMP documentation review, batch record reconciliation, product stability assessment, deviation and OOS investigation, CAPA support, change control evaluation, complaint and recall reporting, inventory control, SOP maintenance, warehouse report analysis, transportation validation support, audit preparation, staff training coordination
Preferred skills
Experience with pharmaceuticals, natural health products, medical devices, contract laboratory operations
Technologies
Microsoft Office (Excel)
Responsibilities
Review GMP documents (master production documents), reconcile GMP documents for product lots, coordinate product release, implement Canadian confirmatory testing for imported products, review warehouse reports, assess disposition of damaged and returned goods, assist with deviations, OOS investigations, CAPA, change controls, complaints, adverse events, and recalls, assist with stability programs, transportation validation, warehouse temperature mapping, self-inspections, external inspections, and update client SOPs.
Seniority
Mid-level IC
