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Documentation Specialist

Excelgens, Phila, PA, United States


Job Title:

Documentation Specialist

Work Location:

112 10381 Decatur Rd 05-0591182 Philadelphia PA 19114 United States

Duration of project:

08 months contract (With possible extension)

Job time:

Mon to Fri (7:30 pm to 4:00 am)

The Documentation Administrator

is responsible for system administration/support of the following Quality Systems

(Documentum and ComplianceWire).

The Documentation Administrator is also responsible for managing

GxP record

archiving activities and document retention / destruction . This individual must be flexible, have well-developed computer.

Responsible: Skills and can interact with all levels of management. Candidate must be a self-starter, organized, results-oriented individual with ability to articulate, receive, disseminate, and analyze data. Responsible for

supporting Document Management activities including preparation, upload, approval, and effectivity of controlled documents. Responsible for the management of Logbooks , including retrieval and reconciliation ensuring department reviews are complete. Responsible for ensuring logbooks are replaced by retire date and archived per procedure. Responsible for completing assigned site administrator training for

Documentum and Compliance Wire

(and other quality systems as assigned). Responsible for archiving GXP documents off-site including document handling, documentation and data entry; storage and retrieval management. Education or Equivalent Requirements: associate degree preferred.

Knowledge/Skills Requirements:

Candidate must have computer skills and capable of quickly learning other software including Documentum and Compliance Wire. Computer proficiency in Microsoft Office products (intermediate) Excellent written and verbal communications skills Well organized with ability to handle multiple activities simultaneously. Ability to work cross-functionally with departments (Operations, Quality Assurance, Supply Chain, Project Management, and Engineering) and individuals at all levels within Catalent

Physical Requirements: • Individual may be required to site, stand, walk regularly • Occasionally lift 5-15 pounds • Be accessible to operations areas and office staff and to use required office equipment • Specific vision requirements include reading written documents and frequent use of a computer monitor.