Stability Coordinator

Strathroy, Ontario is 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.

Position Summary

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.

The Role

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

• Arranges for placement of packaged product into stability chambers (and/or bulk product into warehouse cage), tracks samples in appropriate database(s) 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 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.

• Tracks monthly stability metrics set by Quality Management.

• Perform other duties as required.

The Candidate

• University degree, preferably a bachelor’s degree in Science, Chemistry, Pharmacy, or related field.

• Preferably 3-5 years of experience in QA/QC or related field.

• Preferably experience working in a manufacturing, pharmaceutical and/or GMP facility.

• Excellent computer skills specifically in Microsoft Excel.

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

• ln depth knowledge of soft gel manufacturing and encapsulation processes an asset

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

• Resourceful, innovative, and persuasive.

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

Why you should join Catalent:

• Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance);

• Group Retirement Savings –Registered Pension Plan (RPP) with employer contributions;

• Paid Time Off Programs incl. vacation, banked time & personal time;

• Employee Reward & Recognition programs;

• Opportunities for professional and personal development & growth incl. 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’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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.