QA Documentation Specialist

Job description

Quality Assurance Documentation Specialist The Quality Assurance Documentation Specialist is responsible for reviewing, implementing and maintaining change control to quality documentation and electronic systems such as the electronic batch record system and electronic weigh and dispense system per applicable SOPs. 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. The primary tasks performed will include managing, maintaining, writing, and issuing standard operating procedures, batch records, standard test procedures, specifications, analytical methods, other quality documents, and writing and maintaining computerized system recipes. The Role: Review, issuance, and closure of Document Change Requests (DCRs) in accordance with Catalent’s SOPs for all quality documents (i.e. Engineering Drawings, SOPs, Methods, Model Work Orders, methods, etc.). Maintenance of the Document Change R...