QA Associate
# QA Associate **Rubicon Research** · Concord, ON L4K 4J1 · `On-site` 🕒 **Статус:** *Опубликовано: 3 дня назад* · *Источник: Indeed* --- ### About the Role 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. Pay: $50,000.00-$55,000.00 per year Benefits: - On-site parking Work Location: In person
Наблюдалась 2026-10-19, впервые 2026-10-16, источник — Indeed.