Documentation Specialist
Fladger Associates
Athens, GA
Contract Duration: 6-36 months
Rate: Negotiable
- Excellent employment opportunity for a Documentation Specialist in the Athens, GA area.
- 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.
- Electronic Document Management (controlled documents, regulatory submission documents): Create and configure document templates and support site users in workflow configuration. Provide routine user support.
- Electronic Document Management (controlled documents, regulatory submission documents): 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.
- Understanding of pharmaceutical and biological development processes and documentation is strongly preferred, due to the technical nature of the documents being managed.
- Demonstrated experience managing electronic document management systems, ideally in the Veeva suite of systems in a regulated laboratory environment.
- 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 company policies on Records Management, Training Management, Information Protection.
- The individual must be very detail oriented and able to follow precise instructions.
- Understanding of typical pharmaceutical and/or biological development processes and documentation is strongly preferred.
- Must be able to create clear documentation and manage a workload of several assigned tasks.
- Preferably experience with Documentum, MS Teams, MS Sharepoint.
Vacancy posted 17 hours ago
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