Job Description

Position Title: Documentation Specialist

Work Location: Athens, GA 30601

Assignment Duration: 6 Months

Position Summary: Tech-savvy information management specialist to support GI Development sites / activities. Major activities include: the subject matter expert for electronic document management systems and migration of records from legacy systems.

Key Responsibilities:

Electronic Document Management (controlled documents, regulatory submission documents):

• Create and configure document templates and support site users in workflow configuration.
• Provide routine user support.
• Be the first line of user support for Development users.
• Records Migration: Support necessary transfer projects from origination location to approved document management systems.
• Must be able to follow precise computer system instructions with high attention to detail and minimal oversight.
• Must balance priorities of several ongoing activities.

Qualification & Experience:

• Demonstrated experience managing electronic document management systems, ideally in the Veeva suite of systems in a regulated laboratory environment.
• Preferably experience with Documentum, MS Teams, MS SharePoint.
• Understanding of pharmaceutical and biological development processes and documentation is strongly preferred, due to the technical nature of the documents being managed.
• Bachelor Degree + 2 years relevant experience OR Associates Degree + 2 years experience OR 4 years relevant experience.
• 21CFR Part 11, GLP (FDA and EPA), GMP (FDA and EU), VICH.
• Internal policies on Records Management, Training Management, Information Protection.
• Very detail oriented and able to follow precise instructions.

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