Documentation Specialist

Title:

Documentation Specialist Pay Rate:

$29/ HR.

With Benefits Location:

Durham, NC Duration - 12 Months + Shift Time -

Standard Shift Job Description:

Must Have Requirements Experience with Veeva Vault / EDMS (Electronic Document Management System) Strong skills in document archiving and organizing physical & electronic records Hands-on experience in GMP (Good Manufacturing Practices) environments Strong knowledge of GDP (Good Documentation Practices) Experience in quality systems documentation / document control processes Strong attention to detail and high accuracy in documentation work Excellent communication skills (written & verbal) Strong organizational skills and ability to manage multiple documentation requests Ability to identify issues, escalate problems, and follow compliance procedures Experience in

SAP / ERP

systems (preferred but considered must-have as per requirement need) Background in Pharmaceutical, Biotech, or Medical Device industry Ability to work in regulated environments and maintain inspection readiness

Qualifications:

Bachelor's degree preferable but would accept Associate degree or Highschool 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.

Pay:

$27.00 - $29.00 per hour

Benefits:

Dental insurance Health insurance Vision insurance

Work Location:

In person