QA Document Control Specialist
QA Document Control Specialist ROCGJP00039433
- Hourly pay: $30-$40
- Worksite: Leading biotechnology company (Philadelphia, PA 19104 - Onsite)
- W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
- 40 hours/week, 10 Month Assignment
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.
QA Document Cont rol Specialist 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).
QA Document Contro l Specialist Qualifications:
- 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.
Shift:
- May require occasional shift work, including weekends, off-hours, and holidays as needed.
(H)
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