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Documentation Specialist

4 months ago

Athens, United States LanceSoft Full time

Duties:

Mon - Fri 8:00a - 4:30p
Retention Bonus of (USD)250 at 30 and 60 Days
Were looking for someone with razor sharp attention to detail, documentation-savvy, initiative, strong work ethic, attendance reliable person to support our packaging & labelling department for animal pharmaceutical facility in Athens, GA. Major activities include coordination, assisting in reconciling and reviewing of paper batch packets, maintaining their training, and assisting in requesting, reviewing and revising documents.
Document Management (controlled documents, batch packet documents): fill out, reconcile, and review documentation included in batch records from approved templates.
Comfortable with Inventory Management using Computer Based Software to include SAP or familiarity with Oracle.
Documentation Revisions: Assist in requesting, reviewing and revision documents as needed.
Familiarity with 21CFR, GDPs & GMPs
Training on Internal BI policies on Records Management, Training, Information Protection.
Must be able to follow precise instructions with high attention to detail and minimal oversight. Must balance priorities of several ongoing activities. Understanding of pharmaceutical GMP and GDPs is strongly preferred, due to the technical nature of the documents being managed.

Skills:

Demonstrated experience coordinating documentation, ideally in a regulated manufacturing environment. Preferably experience with Viva, Idea for Con, SAP, MS Teams, MS SharePoint, Excel, PowerPoint, and Word.
The individual must be very detail oriented and able to follow precise instructions. Understanding and familiarity of pharmaceutical documentation is strongly preferred. Must be able to create clear documentation and manage a workload of several assigned tasks.