Quality Assurance Specialist

Initiate change controls, review and prepare Standard Operating Procedures (SOPs) for quality assurance activities, and manage the release of imported drug products by evaluating incoming lot shipment documentation, temperature data, and testing results. Review and maintain batch documentation, Certificates of Analysis, and stability data for imported drug products, coordinate Annual Product Summary Reports, and manage product returns, destruction, and quarantine dispositions. Conduct sampling and inspection activities as needed, manage document retention, and respond to customer service issues while adhering to Canadian Regulations and GMP requirements.