Quality Assurance Associate

Title: Associate, Quality Assurance

Reports to: Assistant Manager, QA

Job Function

• Perform pharmaceutical batch release and product disposition activities for Canada and US markets.
• Provide QA oversight of pharmaceutical distribution operations and ensure compliance with GMP requirements.
• Support controlled substance handling, reconciliation, and documentation in accordance with applicable regulatory requirements.
• Support post-market quality activities, including product recalls, field alerts, market complaints, and related investigations.
• Maintain RRCL’s Quality System in compliance with Health Canada, USFDA, GMP, and applicable regulatory requirements.

Duties and Responsibilities

• Perform QA review and release of pharmaceutical batches for North American markets.
• Review batch manufacturing records, Certificates of Analysis, specifications, laboratory results, deviations, investigations, CAPAs, change controls, and other release documentation.
• Ensure all required manufacturing, testing, and quality documentation is complete prior to batch disposition.
• Coordinate with Manufacturing, QC, R&D, Supply Chain, and external manufacturers to resolve batch-release issues.
• Provide QA oversight of pharmaceutical manufacturing activities and support manufacturing investigations and quality events.
• Support QPIC/AQPIC activities, including controlled substance handling, inventory reconciliation, documentation, and compliance.
• Support field alerts, product recalls, market complaints, and post-market quality investigations.
• Support root cause investigations and CAPA implementation associated with manufacturing and product quality issues.
• Review and approve GMP documentation, SOPs, batch records, and quality records.
• Perform applicable laboratory data and audit-trail reviews to support batch release.
• Support equipment commissioning, qualification, and validation activities where required.
• Support regulatory, customer, and internal audits and provide documentation related to batch release and manufacturing activities.
• Support DEL and other regulatory compliance activities as assigned.
• Perform other duties as assigned by the reporting manager or Site Quality Head.

Skills and Qualifications

• Bachelor’s degree in pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, or related scientific discipline.
• 2–5 years of pharmaceutical industry experience, preferably in Quality Assurance
• Strong experience in pharmaceutical batch release and product disposition.
• Previous experience as a QPIC and/or AQPIC is highly preferred.
• Previous experience in pharmaceutical manufacturing operations is strongly preferred.
• Experience with controlled substances, inventory reconciliation, and regulatory documentation is preferred.
• Experience with field alerts, product recalls, market complaints, and post-market quality activities is preferred.
• Experience with deviations, investigations, CAPA, change controls, and risk assessments.
• Experience with equipment commissioning, qualification, or validation is an asset.
• Knowledge of Health Canada, USFDA, GMP, GDP, and data integrity requirements.
• Strong documentation, technical writing, communication, and problem-solving skills.
• Strong attention to detail and ability to make sound quality decisions under tight batch-release timelines.