Catalent Pharma Solutions Documentation Specialist in Somerset, New Jersey

Job Description

Document Specialist

Position Summary

This is an excellent opportunity to join our knowledgeable staff in our operations department in Somerset, NJ.

Candidate must be flexible and have well-developed organizational skills and have the ability to interact with all levels of management. Candidate must be a self-starter, results oriented individual with ability to articulate, receive, disseminate and analyse data.

The Role

  • Support the site with preparation, circulation, and handling of all standard operating procedures (SOPs) and associated forms, Preventive Maintenance Forms (PMFs), and other documents as required. Other documents may include but are not limited to Specifications, Batch Records, Methods and Protocols.

  • Perform all duties in a manner consistent with cGMPs, as well as site and corporate policies and procedures.

  • Manage the lifecycle of SOPs, PMFs and other document types utilizing Documentum, a Controlled Document Management System.

  • Assist as Site Administrator for Documentum.

  • Provide assistance to site personnel with concerns regarding Documentum.

  • Provide assistance to site personnel with documentation requirements.

  • Monitor, track and report on SOPs, PMFs and other document types in various states.

  • Provide metrics on the status of SOPs and other document types to management.

  • Update and maintain reports on the procedure management process.

  • Develop new procedures and revise existing procedures as required.

  • Prioritize the completion of tasks in a timely manner.

  • Provide training of personnel on Documentum and the procedure management process as required.

  • Provide training of personnel on additional documents and the management of those documents through Documentum.

  • Lead and provide support for company wide projects associated with the management of procedures through Documentum and other document types as required.

  • Perform system qualification as required.

  • Lead document review meetings as required.

  • Represent the Documentation Group on project teams, process improvement teams, management meetings and internal/external forums.

The Candidate

  • Candidate must have a Bachelor’s degree in Science or other related field.

  • A minimum of four to five years of experience working in the Pharmaceutical Industry. Must have at least one year’s experience managing procedures in Documentum. Thorough knowledge of cGMPs with at least 3 year’s documentation experience in the Pharmaceutical Industry.

  • Full understanding of FDA, cGMP, and DEA regulations.

  • Must have at least one year’s of experience with managing procedures in Documentum.

  • Read and understand MSDS requirements and restrictions.

  • Good understanding of procedures related to document control, Quality Assurance and this job function.

  • Previous interaction with Pilot Plant and/or Analytical Laboratories.

  • Must be a self-starter, be able to work independently and have the ability to multi-task under strict deadlines.

Position Benefits

  • Works cross-functionally and receives exposure to several departments and other Catalent Sites

  • Medical, Dental, Vision and 401K are all offered from day one of employment

  • 19 days of paid time off annually + 7 paid holidays

About Catalent

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.

Catalent. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities, or contact us at

+1 877 503 9493.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.