Senior Quality Assurance Associate

Responsibilities

• Ensure compliance with Health Canada regulations, GMP requirements, and internal quality standards.
• Maintain and support continuous improvement of the Quality Management System (QMS).
• Manage deviations, non-conformances, quality complaints, change controls, and CAPAs.
• Review batch documentation and support product disposition activities.
• Coordinate annual product quality reviews and identify quality trends and improvement opportunities.
• Manage product recalls and withdrawals when required.
• Oversee supplier and subcontractor quality performance and maintain quality agreements.
• Participate in internal, external, and regulatory audits and inspections.
• Support inspection readiness and follow-up on audit observations and corrective actions.
• Provide quality guidance and training to internal teams.
• Collaborate with cross-functional stakeholders to ensure ongoing compliance and operational excellence.