Quality Assurance Associate II
Scarborough, Ontario
6 month contract
We are looking for a Quality Assurance Associate II to join our team. In this role, you will be responsible for reviewing and approving stability reports, conducting corporate standard gap assessments, evaluating and closing change controls, and reviewing and approving method transfer protocols and reports, as well as executed batch records.
You will support new product launches and the release of imported products to the Canadian market, including assessing the impact of critical GMP-related issues. The role also involves reviewing supplier documentation related to product launches, product releases, validation activities, deviations, and change controls.
As a Quality Assurance Associate II, you will lead and support investigations related to deviations, Out-of-Specification (OOS), and Out-of-Trend (OOT) results, while ensuring compliance with regulatory and quality requirements. You will maintain establishment licenses for imported products and coordinate renewals as required.
Additionally, you will investigate product complaints and ensure the timely review, closure, and approval of records within the Quality Management System (QMS), collaborating closely with both internal and external stakeholders to drive quality and compliance across operations.
