Documentation Specialist, Analytical Research & Development

Catalent Pharma Solutions • St. Petersburg, FL

3d • Onsite

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 152 hours of PTO + 8 paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level