Quality Assurance Associate

Quality Assurance Associate
About Site

The newly launched manufacturing facility on Adair Blvd marks a pivotal expansion of Catalent’s Zydis® technology, a globally renowned, fast-dissolve oral dosage form that has transformed the lives of millions of patients worldwide. This is your opportunity to join a dedicated team at the forefront of pharmaceutical manufacturing. At Adair, you’ll play a vital role in the startup of a site built for innovation and excellence, from installation and qualification to regulatory approval and commercial manufacturing.

We have an opportunity for a Quality Assurance Associate to join our team and help create a culture of quality compliance and continuous improvement. This role focuses on preventing quality issues and ensuring compliance with government, customer, and business requirements. You will be involved in final product audits, coaching and training on documentation practices, and supporting cGMP standards. Your work will contribute to maintaining the highest quality standards in pharmaceutical manufacturing.

Shift: 8-12 hour rotating continental shifts as defined by rotation schedule.

Location:

Adair, ON
100% Onsite

• Perform in-process document auditing and product quality checks in production, ensuring all issues are communicated to production employees, management, and QA management, including QA sign-off after set-up to confirm compliance with batch documentation and SOPs.
• Conduct final release auditing of batch documentation to ensure products are manufactured in compliance with cGMP and SOPs, including all duties required for final product release.
• Assist in investigating manufacturing issues and deviations reported by production departments; coach and train operators and supervisors on cGMP practices.
• Perform weekly compliance audits in production and packaging departments and prepare reports for QA management.
• Act as QA representative on shift for decision-making and issue resolution, escalating serious issues as required.
• Assist in writing and revising SOPs and support filing, archiving, and review of quality documents.
• Perform finished product blister inspection prior to batch release.
• Perform other duties as assigned.

• Bachelor’s Degree in Science, Engineering (Chemistry, Biochemistry) or related field required.
• This position does not qualify for sponsorship.
• Candidates with non-Canadian credentials must provide an evaluation confirming Canadian equivalency as determined by the Alliance of Credential Evaluation Services of Canada (ACESC) such as WES.
• The role frequently involves sitting and utilizing hands and fingers for tasks such as handling, feeling, and keyboard manipulation, requiring manual dexterity.
• Occasionally requires standing, walking, reaching, bending, twisting, stooping, kneeling, crouching, or crawling, alongside close vision capabilities and potential exposure to chemicals.

• No previous experience required.
• Prior experience in a manufacturing, pharmaceutical, and/or GMP facility would be an asset.
• Strong analytical and problem-solving skills.
• Extremely detail-oriented.
• Excellent communication skills – verbal and written.
• Able to work independently with minimal supervision.
• Experience with coaching or leadership, with the ability to give feedback and implement a quality culture on the production floor.

The final salary offered to a successful candidate may vary within this range $48,000 – $55,000, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a global employer, and…