Quality Assurance Specialist
Location: Mississauga, ON
Industry: Pharmaceutical Distribution & Healthcare Logistics
About the Role
We are seeking a Quality Assurance Specialist to join our growing pharmaceutical distribution team. The successful candidate will be responsible for ensuring compliance with Health Canada regulations, GMP, GDP, and company quality systems while supporting warehouse operations, client projects, audits, controlled substances compliance, and regulatory activities.
Key Responsibilities
- Ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and company Standard Operating Procedures (SOPs).
- Review and approve quarantine, release, inventory adjustments, product holds, and destruction activities.
- Support product relabelling, repackaging, and secondary packaging projects.
- Review shipping temperature excursions and investigate quality events.
- Initiate, investigate, and close deviations, non-conformances (NCRs), CAPAs, and change controls.
- Review warehouse damage reports and communicate quality issues with clients when required.
- Participate in internal, customer, and regulatory audits and assist in responding to audit observations.
- Ensure compliance with the Controlled Drugs and Substances Act (CDSA), the Narcotic Control Regulations (NCR), and applicable Health Canada requirements.
- Review and maintain controlled substances documentation, including inventory reconciliation, receipt, storage, distribution, destruction, and record retention.
- Perform routine audits and inventory reconciliations of controlled substances to ensure regulatory compliance and inventory accuracy.
- Work closely with Operations, Warehouse, Regulatory Affairs, and clients to ensure quality expectations are consistently met.
Preferred Qualifications
- Quality Assurance experience within the pharmaceutical, biotechnology, medical device, or healthcare industry.
- knowledge of GMP, GDP, Health Canada regulations, and pharmaceutical quality systems.
- Experience with deviations, CAPAs, change controls, investigations, complaints, recalls, and audits.
- Experience reviewing warehouse quality records, temperature monitoring, calibration, and environmental monitoring.
- Strong documentation and technical writing skills.
Pay: $40,000.00-$55,000.00 per year
Benefits:
- Dental care
- Life insurance
- On-site parking
- Paid time off
Work Location: In person
