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.
Position Summary
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
The Role
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.
The Candidate
Minimum Requirements
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.
Preferred Skills & Background
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.
Pay
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 this salary range does not reflect positions that work in other countries.
Why You Should Join Catalent
Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance).
Group Retirement Savings – Registered Pension Plan (RPP) with employer contributions.
Employee Reward & Recognition programs.
Opportunities for professional and personal development & growth including tuition reimbursement.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
