Documentation Specialist, Analytical Research & Development
The Documentation Specialist, AR&D is responsible for reviewing, implementing and maintaining change control to quality documentation per applicable SOPs. The primary tasks performed by this individual will include managing, maintaining, writing, and issuing standard operating procedures, standard test procedures, specifications, analytical methods, and other quality documents.
Position Summary
This position is 100% on-site at the St. Petersburg site.
Shift: Monday - Friday 8 am - 5 pm hours
St. Petersburg is our primary Softgel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.
The Role
Review, issuance, and closure of Document Change Requests (DCRs) in accordance with Catalent’s SOPs for all quality documents (i.e.SOPs, Methods, Specifications, etc.) Authoring and modifying SOPs with input from the change initiators.
Compiling and Reviewing all documents associated with new material qualification.
Maintenance of the Document Change Request database; Maintenance of Quality Assurance files for Document Change Requests.
Conducting lifecycle management of quality documents within Documentum.
Printing, binding, and distribution of controlled logbooks for all departments; Assists in the preparation for and facilitation of regulatory and customer audits.
Serves on site project teams. Interfaces with Engineering, Procurement, Quality Control, Quality Assurance, Process Development, Project Managers, Validation and Manufacturing management in support of providing documentation support for new product introductions and for changes to existing products; Ensures that peers and supervisors are informed as to the QA issues that may arise in the projects that may affect progress.
Other duties as assigned.
The Candidate
Requires a Bachelor's degree in a relevant business discipline, technical background in chemistry is preferred.
Requires a minimum of three years' experience with documentation systems, at least one year in the pharmaceutical industry. Solid understanding of cGMPs as they apply to documentation systems.
Direct, hands-on experience with electronic documentation systems; knowledge of Documentum is preferred. Knowledge of LIMS systems, familiarity with bar-coding systems, finished goods label generation, POMS weigh and dispense applications, TrackWise, and JDE is a plus.
Proficient technical writing skills are required.
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 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.
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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.
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