Catalent
St. Petersburg, FL
Shift: Full time
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 Request database. Maintenance of Quality Assurance files for Document Change Requests. Conducting lifecycle management of quality documents within Documentum and computerized systems such as IPC and POMS. Authoring and modifying SOPs with input from the change initiators. Maintenance of the batch record suspension log. Conducting controlled copy printing of master batch records for the production floor. Other duties as assigned. The Candidate Requires a Bachelor s degree in a relevant business discipline or equivalent experience, or applicable combination. A technical background and/or degree in a science (including computer science) is preferred. At least 3 years of experience with documentation systems is preferred (authoring documents in the systems and maintaining the systems), at least 1 year in the pharmaceutical industry is preferred. A minimum of 1 year of experience authoring electronic batch record recipes is preferred. Understanding of cGMPs as they apply to documentation systems. A minimum of 1 year of experience authoring electronic batch record recipes is preferred. Direct, hands-on experience with electronic documentation systems (authoring documents in the systems and maintaining the systems); knowledge of Documentum is preferred. Knowledge of LIMS, finished goods label generation, electronic batch record systems, POMS weigh and dispense applications, and JDE is a plus. Proficiency using computer to create and revise batch records (including in electronic batch record systems) is preferred. Individual may be required to sit for long periods of time, while reading or preparing documents. The individual may also be required to stand or walk. Ability to work effectively under pressure with constantly changing priorities and deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance. Ability to access and move throughout laboratory, production area(s) and office area(s) and use the proper safety precautions as required. Ability to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. 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! 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. 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.