Documentation Specialist - Lancesoft : Job Details

Documentation Specialist

Lancesoft

Job Location : Athens,GA, USA

Posted on : 2025-07-20T06:11:06Z

Job Description :
Job Title: Documentation SpecialistLocation : Athens GA 30601Duration : 12 months Pay Range: $18.00/HR - $20.00/HR Duties:
  • 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.
  • Preferably experience with Documentum, MS Teams, MS Sharepoint.
Skills:
  • 21CFR Part 11, GLP (FDA and EPA), GMP (FDA and EU), VICH
  • Internal BI 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.
Education:
  • Bachelor Degree + 2 years relevant experience OR
  • Associates Degree + 2 years experience OR
  • 4 years relevant experience
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