Quality Management System Specialist

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 Management System Specialist to join our team. In this role, you will maintain the company’s quality management systems to ensure compliance with Good Manufacturing Practices. You will organize and conduct assessments related to suppliers, product complaints, internal compliance, and change control. This position plays a key role in fostering a culture of continuous improvement and operational excellence at the Adair site.

Shift: Monday - Friday, 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute

Location:

Adair, ON 100% Onsite

Participate in various quality system areas, including customer regulatory inquiries, change control, document control, and metrics provision. Maintain the facility’s supplier assessment program, reviewing supplier audit reports, complaints, and material reviews. Lead the internal audit schedule, support self-inspections, review audit reports, and assist with regulatory and customer audits to ensure compliance and inspection readiness. Support the preparation of Quality Systems trend reports, provide recommendations based on observed trends, and lead or support continuous improvement initiatives.

Participate in investigations and corrective action identification or implementation for deviations and complaint documentation, ensuring timely closure. Conduct compliance reviews of site and corporate procedures and support quality improvement initiatives by participating in project teams and executing assigned projects. Develop the Quality Management System for optimal efficiency by leading small teams through the implementation of new systems and ways of working.

Perform other duties as required.

• Diploma or bachelor’s degree in life science or related field required.
• Minimum of 2 years of experience in Quality, Operations, or related field required.
• Experience working in a regulated manufacturing environment required.
• Previous experience in Quality Management System, preferably within the pharmaceutical industry, is highly desirable.
• Experience in preparation and involvement relating to FDA and HPFBI inspections is desirable.
• While performing the responsibilities of the job, the employee is required to talk and hear.
• The employee is often required to sit and use their hands and fingers to handle or feel and to manipulate keys on a keyboard.
• Use of manual dexterity is required.
• The employee is occasionally required to stand, walk, reach with arms and hands, bend, twist, stoop, kneel, crouch, or crawl.
• Vision abilities required include close vision.

• Knowledge of Good Manufacturing Practice compliance and regulatory requirements with a strong understanding of quality systems
• Experience in generating controlled documents
• Strong attention to detail and a high degree of accuracy
• Excellent organizational and time management skills to prioritize tasks, allocate resources effectively, and meet schedules
• Demonstrated ethics and due diligence
• This position does not qualify for sponsorship
• Candidates with non-Canadian credentials must provide an evaluation confirming the Canadian equivalency of the credentials as determined by the Alliance of…