Catalent
Documentation Specialist
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Documentation Specialist is responsible for reviewing, writing, implementing and maintaining documentation such as batch records, protocols, IPC recipes, technical assessments and electronic weigh and dispense system per applicable SOPs. To accomplish these responsibilities the Documentation Specialist will be experienced and have an understanding of document change control procedures, computer systems, and manufacturing process knowledge within a cGMP environment. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. The position is 100% on-site at our St. Petersburg, FL location. The Role
Review, write, or revise master batch records to support new products via technical transfers and initiate improvements/updates for existing commercial products. Review, write or revise Technical Services protocols to support technical transfers, qualification of alternate suppliers, manufacturing gap assessments or other protocol-driven tasks for the Technical Services department. Review, write or revise IPC recipes for new products or existing commercial products. Review, write or revise electronic weigh and dispense system recipes (POMS). Review, write, or revise technical assessments with input from department SMEs. Review, write, or revise SOPs with input from the change initiators. Review, write, or revise Change Control in accordance with Catalent's SOPs. Addend master batch records prior to execution in support of Technical Services protocols and other associated functions. Maintain all Technical Services documents, electronically or physically, for immediate, rapid retrieval. Electronically scan completed Technical Services documentation, as needed. Perform training on documents with cross-functional teams, as needed. Other duties as assigned. The Candidate
Bachelor's degree is required. 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. 3+ years' experience with documentation systems is preferred (authoring documents in the systems and maintaining the systems), 1+ years in the pharmaceutical industry is preferred. 1+ years' experience authoring electronic batch record recipes is preferred. 1+ years of experience authoring written and electronic batch record recipes 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 0-15 pounds. 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 Join Catalent:
Tuition Reimbursement
Let us help you finish your degree or earn a new one! WellHub program to promote overall physical wellness. 152 hours of PTO + 8 paid holidays. Medical, dental and vision benefits effective day one of employment. Defined career path and annual performance review and feedback process. Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives. Dynamic, fast-paced work environment. Positive working environment focusing on continually improving processes to remain innovative. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. 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.
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Documentation Specialist is responsible for reviewing, writing, implementing and maintaining documentation such as batch records, protocols, IPC recipes, technical assessments and electronic weigh and dispense system per applicable SOPs. To accomplish these responsibilities the Documentation Specialist will be experienced and have an understanding of document change control procedures, computer systems, and manufacturing process knowledge within a cGMP environment. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. The position is 100% on-site at our St. Petersburg, FL location. The Role
Review, write, or revise master batch records to support new products via technical transfers and initiate improvements/updates for existing commercial products. Review, write or revise Technical Services protocols to support technical transfers, qualification of alternate suppliers, manufacturing gap assessments or other protocol-driven tasks for the Technical Services department. Review, write or revise IPC recipes for new products or existing commercial products. Review, write or revise electronic weigh and dispense system recipes (POMS). Review, write, or revise technical assessments with input from department SMEs. Review, write, or revise SOPs with input from the change initiators. Review, write, or revise Change Control in accordance with Catalent's SOPs. Addend master batch records prior to execution in support of Technical Services protocols and other associated functions. Maintain all Technical Services documents, electronically or physically, for immediate, rapid retrieval. Electronically scan completed Technical Services documentation, as needed. Perform training on documents with cross-functional teams, as needed. Other duties as assigned. The Candidate
Bachelor's degree is required. 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. 3+ years' experience with documentation systems is preferred (authoring documents in the systems and maintaining the systems), 1+ years in the pharmaceutical industry is preferred. 1+ years' experience authoring electronic batch record recipes is preferred. 1+ years of experience authoring written and electronic batch record recipes 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 0-15 pounds. 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 Join Catalent:
Tuition Reimbursement
Let us help you finish your degree or earn a new one! WellHub program to promote overall physical wellness. 152 hours of PTO + 8 paid holidays. Medical, dental and vision benefits effective day one of employment. Defined career path and annual performance review and feedback process. Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives. Dynamic, fast-paced work environment. Positive working environment focusing on continually improving processes to remain innovative. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. 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.