Job Description

Position Summary

The Quality Compliance Coordinator reports to the Compliance Manager, the Compliance Associate supports key compliance initiatives relating to Customer/Regulatory GMP inspections and tracks completion of audit commitments. In addition, the incumbent also leads Pharmacopeial update processes and supports the Stability Program.

This position is located in Windsor, Ontario, one of two sites located in Canada offering softgel development and manufacturing capabilities for the Pharmaceutical and Consumer Health industries. We have a broad range of integrated formulation, manufacturing, analytical and packaging services to offer full-service turnkey solutions.

Shift: Onsite - Regular working hours: 8:00 AM \xe2\x80\x93 4:30 PM or 8:30 AM \xe2\x80\x93 5:00 PM with a 30-minute unpaid lunch.

The Role

• Support the QA Manager (Compliance) during customer GMP inspections.
• Conducts site walkthroughs to ensure site readiness. Works with Area Supervisors to resolve deficiencies. Collects and pre-reviews requested documents in advance and during site inspections. Coordinates internal responses and prepares final report for approval.
• Tracks audit CAPA for completion of internal commitments, ensuring timelines are met. Maintains and reports relevant metrics.
• Manage and maintain the Reduced Testing Program. Support annual Self Inspections.
• Pharmacopeial Updates: Monitor appropriate websites and other publications for periodic updates relating to USP testing Monographs. Disseminates relevant information for internal review by key stakeholders. Schedules and leads routine meetings with key stakeholders. Coordinates updates to internal specifications and procedures as required.
• Support Stability Program: Prepares Stability Summary Reports from reviewed Analytical Reports as needed to support the Stability Coordinator. Obtains approval signatures from the Compliance Manager(s). Prepares PDF files of external reports for Sales Department use.
• Support Special Projects / Initiatives: Assist the Compliance Manager in ensuring that projects and objectives are accomplished as assigned. Perform other duties as required (i.e. trend reports, responding to customer inquiries, cross training with other members of the Compliance team, etc.)
• Perform other duties as required.

The Candidate

• Bachelor\xe2\x80\x99s Degree in Life Sciences (Chem., BioChem.) or related field.
• Minimum 1-3 years of experience in quality assurance or related field.
• Experience working in a pharmaceutical, laboratory and/or GMP regulated environment.
• Able to effectively communicate with all types of staff, including technical, professional, and upper management. Strong analytical skills, extremely detailed oriented along with strong interpersonal skills.

• Advanced computer skills in Microsoft Office products including Word, Excel, Outlook and Access.
• While performing the responsibilities of the job, these work environment characteristics are representative of the environment the employee will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.

Why You Should Join Catalent

• Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)
• Group Retirement Savings \xe2\x80\x93Registered Pension Plan (RPP) with employer contributions.
• Paid Time Off Programs including vacation, banked time & personal time.
• 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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone\xe2\x80\x99s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

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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 . 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.

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