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Documentation Specialist

Spectraforce Technologies
United States, North Carolina, Durham
5325 Old Oxford Road (Show on map)
May 22, 2025
Documentation Specialist

6 months

Durham, NC 27712

Qualifications:

Bachelor degree preferable but would accept AA or Highschool Diploma with two years related GMP Biopharma experience

Knowledge in Veeva/electronic document management system.

Knowledge in Archiving or organizing physical documents.

Data Entry computer skills.

GMP experience.

Responsibilities:

The primary responsibilities for the Quality Systems Documentation Management position:

1. Document issuance and reconciliation using an electronic document management system (Veeva)

2. Archiving assistance in the High Density Storage Room (HDSR)

3. Assist system owners to keep the site inspection ready

4. On site position

The role is a contract position that requires the incumbent to adhere to global and site procedures pertaining to the functions of the role.

5. Knowledge using a quality system for documentation.

6. Updating a Record Inventory Management System (PRIMS) for archived paper documents; includes archiving documents and completing document check-out requests.

7. Issuing and Reconciling issued documents using an electronic document management system (Veeva).

8. Helping the team organize paper batch records from SAP for issuance.

9. Ensuring appropriate Good Documentation Practices (GDP) when entering the data into the system.

10. Guide others to Quality System procedures and processes to ensure that requests are made appropriately.
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