Documentation Specialist
Fladger Associates
Athens, GA Contract Duration: 6-36 months Rate: Negotiable Responsibilities: 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. Experience: 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. Fladger Associates
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