QA Document Control Specialist

Avispa Technology•Philadelphia, PA

1d•$30 - $40•Onsite

About The Position

A leading biotech company is looking for a QA Document Control Specialist . The candidate will work to develop, deploy, and support the Veeva Quality Document System, manages, and tracks all GMP documentation.

Requirements

2-5 years of experience in working with documentation in a regulated industry.
BS/BA in Biology, Chemistry, Engineering, related science discipline.
Computer literacy required; advanced Microsoft Office skills (Outlook, Word, Excel, PowerPoint)
Knowledge of GMP concepts and guidelines.
Experience with document control activities.
Experience with document control systems.
Effective knowledge of maintaining a document and data control system.
A general understanding of FDA regulatory requirements as they relate to documentation.
Extensive MS Word processing and formatting experience.
Experience in automating processes utilizing MS Office products.

Responsibilities

Manage and maintain controlled documents in Electronic Document Management System (EDMS) ensuring documents go through controlled documents life cycle in accordance established procedures.
Coordinate the review, finalization, and archival of Spark policies, procedures, and other controlled documents.
Manage EasyVista (EV) on all incidents and requests for the EDMS and close all tickets in a timely manner.
Serve as an administrator of the EDMS including user account management, system configuration, troubleshooting and work with EDMS vendor(s).