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
GMP-compliant pharmaceutical and biopharma products
Domain
Life Sciences / Biopharma / Quality Assurance
Required skills
GMP compliance, batch record reconciliation, stability program assessment, CAPA investigation, change control, complaint handling, deviation analysis, SOP management, inventory control, regulatory document review
Preferred skills
Pharmaceutical product experience, contract laboratory experience, natural health products knowledge, medical devices knowledge
Technologies
Microsoft Office (Excel)
Responsibilities
Review and reconcile GMP documents (master production documents, batch records, CoA, CoM, label reviews); 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; Support transportation validation, temperature mapping, and stability studies; Assist with self-inspections and external audits; Maintain GMP documents and client SOPs; Support staff training.
Seniority
Junior, hands-on IC
