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Documentation Specialist Assistant

Job in Durham, Durham County, North Carolina, 27712, USA
Listing for: Integrated Resources, Inc
Full Time position
Listed on 2026-07-05
Job specializations:
  • Administrative/Clerical
    Clerical, Data Entry, Office Administrator/ Coordinator
Job Description & How to Apply Below
Position: Documentation Specialist - I (Assistant)
Qualifications:

Bachelor degree preferable but would accept Asscoaite degree or High school Diploma with 2 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.

Required:

Excellent written and verbal communication skills.
Collaborative
Detail orientation
Organization skills
Able to escalate issues
Responsibilities:
The primary responsibilities for the Quality Systems Documentation Management position:
Document issuance and reconciliation using an electronic document management system (Veeva)
Archiving assistance in the High Density Storage Room (HDSR)
Assist system owners to keep the site inspection ready
Knowledge using a quality system for documentation.
Updating a Record Inventory Management System (PRIMS) for archived paper documents; includes archiving documents and completing document check-out requests.
Issuing and Reconciling issued documents using an electronic document management system (Veeva).
Helping the team organize paper batch records from SAP for issuance.
Ensuring appropriate Good Documentation Practices (GDP) when entering the data into the system.
Guide others to Quality System procedures and processes to ensure that requests are made appropriately.
On site position, this role is a contract position that requires the incumbent to adhere to global and site procedures pertaining to the functions of the role.
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