Quality Assurance Associate

Job summary

Review and release pharmaceutical batches for Canadian and US markets, ensuring manufacturing, testing, and quality documentation meets applicable GMP and regulatory requirements. Provide quality oversight for manufacturing and distribution, controlled substances, audits, and post-market activities such as recalls, field alerts, and complaints.

Job details

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.

What you’ll do

Review and release pharmaceutical batches for Canadian and US markets, ensuring manufacturing, testing, and quality documentation meets applicable GMP and regulatory requirements. Provide quality oversight for manufacturing and distribution, controlled substances, audits, and post-market activities such as recalls, field alerts, and complaints.

Requirements

A bachelor’s degree in pharmacy or a related scientific discipline and 2–5 years of pharmaceutical industry experience are required, preferably in Quality Assurance and batch release. Candidates should have knowledge of Health Canada, USFDA, GMP, GDP, and data integrity requirements, with experience in investigations, CAPA, change controls, and preferably controlled substances and QPIC/AQPIC activities.

Listed skills

• Quality assurance · Preferred
• Inventory Reconciliation · Preferred
• Root Cause Analysis · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Pharmaceutical Batch Release
• Product Disposition
• GMP Compliance
• Quality Assurance
• Batch Record Review
• Deviation Investigations
• CAPA
• Change Control
• Controlled Substance Compliance
• Inventory Reconciliation
• Post-Market Quality Activities
• Root Cause Analysis
• Data Integrity
• Regulatory Documentation
• Equipment Qualification and Validation
• Technical Writing

Job areas

• Manufacturing
• Healthcare
• Science & Research

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