QA Associate (Temporary contract) - Eurofins BioPharma Product Testing Toronto, Inc.

The QA Associate will be responsible for providing documentation and technical support for designated clients under the supervision of Senior Quality Consultant and Manager, Regulatory and QA Consulting:

Responsibilities:

• Review of GMP documents (including, but not limited to, master production documents);
• Reconcile GMP documents for product lots requiring QC disposition (Batch records, Certificate of Analysis and Certificate of Manufacture, Product Label Reviews);
• Coordinate the release of product to ensure all product released are of good quality and in compliance with GMPs;
• Implement Canadian confirmatory testing for imported products;
• Review of warehouse reports;
• Ensure that products received are transported, handled, sampled, stored, and destroyed correctly;
• Ensure familiarity with client contracts, including agreed upon responsibilities;
• Ensure familiarity with client establishment licences, including approved foreign sites;
• Assess, trend and evaluate product stability programs to ensure compliance;
• Assist with deviations and out-of-specification investigations;
• Assist with Corrective Action and Preventative Action (CAPA) investigations;
• Assist with change controls and ensure they are evaluated and documented;
• Assist with evaluation of complaints, reporting of adverse events and recalls;
• Assess the disposition of damaged goods;
• Assess the disposition of returned goods;
• Assist with protocols/reports for transportation validation, warehouse temperature mapping or stability studies;
• Assist with self-inspections and external inspections;
• Assist with ongoing tracking and maintenance of GMP documents;
• Initiate and assist with updates to clients’ Standard Operating Procedures;
• Support with staff SOP training and ensure training records are compliant;
• Adhere to the clients’ Standard Operating Procedures;
• Attend audits on behalf of clients, ensuring thorough understanding of client needs and requirements;
• Adhere to Company expectation for service standard;
• Ensure accurate inventory control and distribution records;
• Attend staff meetings;
• Any other duties as delegated by the management.