The purpose of this position 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. This position reports to the Manager, Document Control.
The Document Control Associate 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 Teams.
Veeva EDMS Super User manage document/record workflows and run reports.
Scan, index and upload documents and records in to EDMS.
Support Quality Management Systems (i.e., Deviation, CAPA, Change Control, Audits)
Maintenance of electronic and/or hard-copy archives for applicable GxP records.
Additional Skills & Qualifications:
A minimum of three years' experience working within a GMP regulated environment preferred.
Strong communication skills (written and verbal).
Practical understanding of documents and records used within the Pharmaceutical industry.
Prior experience in scanning, indexing and archiving of records.
Self-motivated, flexible & creative, able to prioritize, multi-task and work in a fast-paced & demanding environment.
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.