Documentation Specialist I

Documentation Specialist I Durham, NC 27712 06

Months Description:

Qualifications:

Bachelor 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. 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.

Pay:

$27.17 - $29.25 per hour

Benefits:

Dental insurance Health insurance Vision insurance

Work Location:

In person