About the role
Mint Pharmaceuticals is hiring a Quality Assurance Associate to join its quality team in Mississauga, Ontario. This is a full time hybrid role with a salary range of $62,000 to $70,000 per year.
You will own the preliminary review of documents for product release, review executed batch records, and track third party testing and stability data. You will work closely with warehouse staff, contract fabricators and foreign sites to ensure every product released to market is fully compliant with current Health Canada GMPs.
For a candidate with exceptional depth, there is scope for this position to be set at Senior QA Associate level.
What you will do
- Conduct the preliminary review of documents for product release, including executed batch documentation.
- Coordinate finished product testing and review the quality documentation required to release finished products to market.
- Ensure SOPs across product importation, distribution, testing, warehousing and quality assurance remain compliant with current Health Canada GMPs.
- Assist with and execute product recalls as required by company policy and Health Canada.
- Approve products intended for destruction.
- Perform temperature downloads, and define and execute temperature mapping where applicable.
- Coordinate with warehouse staff on incoming product inspection and label review.
- Maintain retain sample inventory, including the annual physical inventory of retain samples.
- Communicate promptly on documentation and release issues, including delays from contract fabricators and deviation investigations.
- Collect and review technical records from foreign sites, such as method and process validation protocols and reports.
- Track stability for commercial and submission lots and ensure data supporting shelf life is properly filed.
- Interface with third party and foreign site organizations on GMP matters to meet Canadian GMP requirements.
What we are looking for
- Minimum three years of quality assurance experience in a Canadian generic pharmaceutical environment.
- Working knowledge of Canadian GMPs and relevant Health Canada policies and guidances.
- Bachelor of Science in a science related discipline. Postgraduate training in Pharmaceutical Quality Studies is an asset.
- Hands on experience reviewing and dispositioning executed batch records.
- Works independently with minimal supervision and is decisive by nature.
- Meticulous, detail oriented, and highly organized across multiple concurrent projects.
- Strong problem solving and analytical ability, with a track record of issue resolution and process improvement.
- Excellent written and verbal communication skills.
- Proficient in Microsoft Excel, Word and PowerPoint.
Applications are managed by Rossi Recruitment on behalf of Mint Pharmaceuticals.
