Documentation Specialist

Documentation Specialist

Position Summary

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.

St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year.  The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates.  Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation.

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.

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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.