Quality Management System Specialist

Catalent Pharma Solutions; Strathroy; On-site; CAD 56,000 - 65,000; Full time

Benefits offered by this job

Health benefits

Pension plan

Rewards program

Tuition reimbursement

Job summary

Catalent Pharma Solutions in Adair, ON is hiring a Quality Management System Specialist to maintain GMP-compliant quality systems. You will manage supplier assessments, change control, and document control while leading continuous improvement initiatives.

The role requires at least 2 years in a quality/operations field, with a focus on regulated manufacturing and potential FDA/HPFBI inspection involvement. Onsite schedule is Monday–Friday in Adair, ON.

Qualifications

• Diploma or bachelor’s degree in life science or related field.
• Minimum of 2 years of experience in Quality, Operations, or related field.
• Experience working in a regulated manufacturing environment.
• Experience with FDA/HPFBI inspections is desirable.

Responsibilities

• Participate in 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.
• Develop the Quality Management System for optimal efficiency by leading small teams through the implementation of new systems and ways of working.

Skills

GMP compliance

Quality systems

Regulatory audits

Documentation control

Education

Bachelor's degree in life science or related field

Tools

Microsoft Office

Quality management software

Job description

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 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

The Role

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.

The Candidate Minimum Requirements

• 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.

Preferred Skills & Background

• 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 Credential Evaluation Services of Canada (ACESC) such as World Education Services
• Excellent communication (written and verbal) and interpersonal skills
• Strong computer skills including Microsoft Office Suite (Outlook, Excel, PowerPoint, Word) and familiarity with quality management systems and related software is advantageous
• Ability to respond quickly to a changing regulatory environment

Pay

The final salary offered to a successful candidate may vary within this range $56,000 – $65,000, 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.

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.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.