Stability Coordinator (Contract)

Stability Coordinator (Contract)

Position Summary

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.

This position is located in Strathroy, 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.

Reporting to the Compliance Manager, the Stability Coordinator will manage, coordinate and maintain the commercial stability program in addition to ensuring compliance with GMPs and company policies with respect to stability trials.

- Regular working hours: Monday - Friday, 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute unpaid lunch.

- 18-month contract

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role

• Prepare stability protocols and master testing records based on supplied information from customers or internal sources.

• Arranges for placement of packaged products into stability chambers (and/or bulk products into warehouse cage), tracks samples in appropriate databases including the inputting of information into MS Projects & Workfront.

• Arranges for samples to be pulled for QC testing, tracks submission of QC results, enters onto summary sheets, and forwards approved summary sheets to project owner/ customer as applicable. Ensures compliance to stability timelines.

• Prepares Stability Summary Reports from reviewed summary sheets as needed. Obtains approval signatures from the authorized individual(s). Prepares PDF files of external reports for Sales Department use. Responds to customer inquiries.

• Track any commercial Stability deviations, and corrective actions, updating the deviation system as required, and ensuring that timelines are adhered to.

• Participates in the generation of historical data and relevant information during stability investigations.

• Assist the Manager and Director in ensuring that projects and objectives are accomplished as assigned.

• Perform other duties as required.

The Candidate

• Bachelor’s degree in science, Chemistry, Pharmacy or related field is required.

• 3+ years of experience in QA QC or related field is preferred.

• Experience working in a manufacturing, pharmaceutical and/or GMP facility is preferred.

• Excellent computer skills specifically in Microsoft Excel.

• Able to effectively communicate with all types of staff, including technical, professional, and upper management.

• In depth knowledge of consumer health products manufacturing and encapsulation processes is an asset.

• Ability to influence stakeholders, build trust and respect within the overall organization.

• Resourceful, innovative and persuasive.

• Currently Catalent does not participate in the Ontario Immigrant Nominee Program (OINP).

• 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 WES.

• The employee's role frequently involves sitting and utilizing hands and fingers for tasks such as handling, feeling, and keyboard manipulation, necessitating manual dexterity.

• Occasionally, the position requires standing, walking, reaching, bending, twisting, stooping, kneeling, crouching, or crawling, alongside close vision capabilities and potential exposure to chemicals.

Why You Should Join Catalent:

• Opportunities for professional and personal development & growth.

• Several Employee Resource Groups focusing on D&I.

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 DisabilityAccommodations@catalent.com. 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.