Stability Coordinator

Catalent Pharma Solutions•St. Petersburg, FL

4d•Onsite

About The Position

Stability Coordinator The Stability Coordinator will play a key role in supporting the site’s 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 Catalent’s 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.

Requirements

Bachelor’s degree in a related scientific discipline and 3 years of experience with documentation systems and cGMP-compliant environments required.
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.

Nice To Haves

Experience with LIMS and sample tracking preferred.

Responsibilities

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.