Documentation Specialist, Analytical Research & Development

Job description

Documentation Specialist, Analytical Research & Development The Documentation Specialist, AR&D is responsible for reviewing, implementing and maintaining change control to quality documentation per applicable SOPs. The primary tasks performed by this individual will include managing, maintaining, writing, and issuing standard operating procedures, standard test procedures, specifications, analytical methods, and other quality documents. Position Summary: This position is 100% on-site at the St. Petersburg site. Shift: Monday - Friday 8 am - 5 pm hours St. Petersburg is our primary Softgel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges. T he Role: Review, issuance, and closure of Document Change Requests (DCRs) in accordance with Catalent’s SOPs for all quality documents (i.e.SOPs, Methods, Specifications, etc.) Authoring and modifying SOPs with input from the change initiators. Compiling and Reviewing all documents associated with new material qualification. Maintenan...