Quality Assurance Associate (Contract position - 11 months)
About Site
Catalent’s Windsor, Ontario facility is a modern site dedicated to the development and manufacturing of softgel technologies for the pharmaceutical and consumer health industries. The location supports a wide range of products and services, providing an environment where innovation and quality are at the forefront. With advanced capabilities and a strong focus on collaboration, the Windsor site plays a key role in delivering solutions that improve patient health worldwide. This dynamic setting offers employees the opportunity to work with cutting-edge technologies and contribute to meaningful projects in a supportive and professional atmosphere.
Position Summary
We have an opportunity for a Quality Assurance Associate (Contract position - 11 months) to join our team. In this role, you will help create a culture of quality, compliance, and continuous improvement. You will focus on preventing quality issues and support operators and supervisors with training on proper documentation and current Good Manufacturing Practice requirements. This position plays a key role in ensuring compliance and maintaining high standards across operations.
Shift: 12 hour rotating continental shifts (Days and Nights)
Location: Windsor, ON
100% Onsite
The Role
Perform in-process batch review of documentation to ensure compliance with current Good Manufacturing Practices and Standard Operating Procedures, including coaching and training employees and supervisors on identified issues.
Assist in initiating manufacturing events and deviations reported by production departments, ensuring product with potential quality issues is acceptable for release and reports are updated.
Perform line clearance verifications of equipment and processing areas during product changeovers, which may include testing and verification of vision equipment.
Act as Quality Assurance representative on shift for decision-making and issue resolution, escalating serious issues to management as required.
Issue, review, and file various operational logs, including equipment and temperature/relative humidity logs.
Monitor Good Manufacturing Practice compliance in operating areas to maintain inspection readiness.
Participate in special projects in other quality and compliance areas and work extended hours or weekends as needed to meet deadlines or resolve issues.
Perform other duties as required.
The Candidate
Minimum Requirements
Bachelor’s degree in science (Chemistry or Biochemistry preferred) is required.
Experience working in a manufacturing, pharmaceutical, and/or Good Manufacturing Practice facility is an asset.
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 such as World Education Services.
The role frequently involves sitting and using hands and fingers for tasks such as handling, feeling, and keyboard manipulation, requiring manual dexterity. Occasionally, it requires standing, walking, reaching, bending, twisting, stooping, kneeling, crouching, or crawling, along with close vision capabilities and potential exposure to chemicals.
Preferred Skills & Background
Advanced computer skills in Microsoft Office Suite (Outlook, Excel, Access, Word).
Strong analytical and interpersonal skills.
Extremely detail-oriented.
Excellent verbal and written communication skills.
Able to work independently with minimal supervision.
Pay
The final salary offered to a successful candidate may vary within this range $48,000 – $57,000, 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 with employer contributions.
Employee Reward & Recognition programs.
Opportunities for professional and personal development and 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.
