Quality Assurance Associate and -QPIC

Job Summary

The Quality Assurance Associate (Infusion & Compounding Pharmacy) and A-QPIC (Controlled Drugs), under the direction of the Manager, Quality & Risk Management, will support the implementation and maintenance of GxP Quality Systems and participate in quality improvement initiatives, and develop policies, procedures, and education materials to support the business. The incumbent will support the assigned business lines with GMP, A-QPIC and DPP related Quality activities in line with respective regulations outlined by Health Canada and College of Pharmacy.

Occasionally, this position may provide support to other business lines as deemed appropriate by the Quality Management team.

Work Arrangement:
This role requires on-site presence, as it also carries responsibilities as the Alternate Qualified Person in Charge (A-QPIC), which requires on-site verification of processes and completion of required signoffs for narcotic products.

• Participates in the development, implementation and maintenance of Quality Management System, Document Management System and Learning Management System.
• Responsible for ensuring compliance with Health Canada requirements for controlled drugs under the Controlled Drugs and Substances Act (CDSA) and Narcotic Control Regulations, as well as compliance with Medical Device Establishment License (MDEL) requirements as a distributor, including oversight of complaint handling, incident reporting, recalls, required records, and inspection readiness.
• Acts as a back-up for QPIC. Maintains QA and A-QPIC oversight of processes for receiving, storing, compounding, dispensing, transporting and destroying controlled drugs.
• Authors and participates in review/approval of SOPs related to controlled substances/ Medical Device regulations and ensure strict document control.
• Oversees inventory reconciliation, discrepancy investigations and complete controlled drugs monthly Health Canada reporting (Monthly Activity Report-MAR) requirements.
• Performs security, access control and chain-of-custody measures for controlled drugs.
• Reviews batch records for compounded controlled drugs to ensure compliance with approved formulations and requirements.
• Leads investigations and CAPA for incidents involving controlled or hazardous drugs.
• Prepares for and support internal audits, spot audits and Health Canada inspections.
• Supports quality oversight of hazardous and cytotoxic drugs, including safe handling, cleaning, PPE use and environmental controls.
• Ensures compliance with NIOSH and applicable provincial OHS requirements for hazardous drugs.
• Provides training and competency oversight for staff handling controlled or hazardous drugs.
• Conducts Policy, SOP and Work Instruction reviews and revisions, participates in the development of new policies, procedures, and SOPs, and performs their efficacy analysis. Helps ensure appropriate training assignments on rolled-out policies, procedures, and SOPs, including proper communication to all employees.
• Supports management of Quality Events (QEs) and deviations. Conducts root cause analysis, investigations and ensures the CAPA plan is effective and closes on time. This will require education, coordination, and collaboration across the team with all internal stakeholders. Assists with quality event trends analysis and resulting improvement initiatives.
• Identifies training needs, participates in the development of training materials, and leads training to meet quality management standards and contractual requirements.
• Educates internal stakeholders on key quality deliverables and identifies process improvements to increase efficiency, effectiveness, and quality.
• Liaises with Quality leads from other business lines to collaborate on initiatives or adapt mutually beneficial processes.
• Performs other duties as assigned.

• Master’s degree in a scientific discipline is highly preferred but at a minimum possess bachelor’s degree in chemistry, biology or in health sciences.
• ASQ Quality certification, ISO Quality Management or Medical Devices or Auditor certification, or equivalent Quality/Pharmaceutical Sciences/Regulatory…