Documentation Specialist

Job Title: Documentation Specialist

Location : Athens GA 30601

Duration : 12 months

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