JobMesh

Stability Coordinator

Catalent Pharma Solutions · St. Petersburg, Florida, US

Stability Coordinator The Stability Coordinator will play a key role in supporting the site’s Stability Program by generating stability protocols, initiating...

Job description

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. 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...