Stability Coordinator
The Stability Coordinator will play a key role in supporting the siteās Stability Program by generating stability protocols, initiating stability studies, coordinating sample management activities, and ensuring compliance with cGMP, SOPs, and ICH guidelines.
Position Summary
This position is 100% on-site at the St. Petersburg site.
Join Catalentās flagship Softgel development and manufacturing facility in North America, located in St. Petersburg, FL, with a capacity of 18 billion capsules per year. This role offers competitive pay, day-one benefits, and career growth in a state-of-the-art, turn-key facility.
Stability Coordinator supports the Quality Assurance department by maintaining compliant and accurate stability operations. This includes protocol creation, study initiation, sample retrieval, documentation, data entry, and support of investigations, quality agreements, and corrective actions.
The Role
Generate stability protocols and define storage conditions and pull points for stability studies.
Initiate stability storage and ensure proper sample handling, retrieval, labeling, and documentation.
Enter studies into the computerized stability management system in accordance with SOPs.
Compile, interpret, and evaluate data and identify impacts related to deviations, OOS/OOT results, or excursions.
Maintain inventory, coordinate final sample destruction, and reconcile stability materials.
Prepare samples for shipment, complete related documentation, and perform peer reviews.
Ensure compliance with cGMP, quality policies, and Environmental Health & Safety guidelines.
All other duties as assigned.
The Candidate
Bachelorās degree in a related scientific discipline and 3 years of experience with documentation systems and cGMP-compliant environments required.
Experience with LIMS and sample tracking preferred.
Strong organizational, technical writing, and communication skills.
Knowledge of stability program expectations, sample handling, data integrity, and QMS principles.
Proficiency with Microsoft Outlook, Excel, and Word.
Why You Should Work At Catalent
Spearhead exciting and innovative projects
Fast-paced, dynamic environment
High visibility to members at all levels of the organization
152 hours of PTO + 8 paid holidays
Catalent offers rewarding opportunities to further your career!Ā 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.Ā
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
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.
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