Documentation Specialist, Analytical Research and Development Expert

4 weeks ago

St Petersburg, United States Catalent Inc Full time
Job Summary

Catalent Inc is seeking a highly skilled Documentation Specialist, Analytical Research and Development to join our team. As a key member of our quality team, you will be responsible for reviewing, implementing, and maintaining change control to quality documentation per applicable SOPs.

Key Responsibilities

Review, issuance, and closure of Document Change Requests (DCRs) in accordance with Catalent SOPs for all quality documents (i.e. SOPs, Methods, Specifications, etc.).
Compiling and reviewing all documents associated with new material qualification.
Maintenance of the Document Change Request database.
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.
Support Technical Services/ Engineering/Quality Control/Validation schedules in accordance with customer and internal project commitments to minimize disruption of the project and provide documentation in support of business needs.
Ensures the adherence to the standards of quality ruled by the current Good Manufacturing Practices and the Company's Quality Policies.
Participates in the creation and review of current and proposed procedures.

Requirements

Bachelors degree in a relevant business discipline required. A technical background in chemistry is preferred.
3 years experience with documentation systems, at least 1-2 years in the pharmaceutical industry and a solid understanding of cGMPs as they apply to documentation systems required.
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.
Must be well organized, an effective communicator at multiple levels, able to grasp system concepts and communicate their applications.
Must be capable of managing multiple projects with time related constraints in a fast-paced contract manufacturing environment.
Must possess strong technical writing skills and be able to speak effectively before groups of internal and/or external customers or employees.
Authoring and modifying SOPs with input from the change initiators.
Exemplary oral and written communication skills.
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 Catalent

Catalent offers a dynamic, fast-paced work environment with a positive working environment focusing on continually improving processes to remain innovative. We are committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. We offer a diverse, inclusive culture with several Employee Resource Groups focusing on D&I. Community engagement and green initiatives are also a part of our company culture. We provide tuition reimbursement, a WellHub program to promote overall physical wellness, 152 hours of PTO, 8 paid holidays, medical, dental, and vision benefits effective day one of employment, a defined career path, and annual performance review and feedback process. We also offer a Perkspot program with exclusive discounts from approximately 900 merchants in a wide array of categories.

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