Document Control Specialist
The purpose of the Document Control Specialist is to assist in the management of Quality Assurance and other essential documents via the use of the company Electronic Document Management System (EDMS), Veeva Vault.
The Document Control Specialist is expected to have a working knowledge of FDA regulations concerning Good Manufacturing Practices (GMP) in order to ensure compliance to quality standards for documentation, change control, and records management.
The ideal candidate will have experience in using Microsoft SharePoint and Veeva EDMS.
Skills for the Document Control Specialist:
- Training and support of Veeva EDMS end users.
- Scan, index and upload documents and records in to EDMS. Maintenance of electronic and/or hard-copy archives for applicable GxP records. *Document control support for CMO.
- 3+ years of Quality Assurance, Document Control, Records Management or Manufacturing experience in a biotech or pharmaceutical company preferred.
- 2+ years experience working within a GMP regulated environment preferred.
*Strong communication skills (written and verbal) and customer service skills.
*Practical understanding of documents and records used within the Pharmaceutical industry.
*Working knowledge of SharePoint desired.
*Experience with EDMS workflows desired.
*Experience using a Learning Management System (LMS) desired.
*Must be knowledgeable of industry documentation types and Good Documentation Practices (GDP).Education:
Bachelors Degree in a life sciences related field preferred