QA Documentation Specialist
Somerset County, NJ - USA
Job Summary
Job Description:
Position Title: QA Documentation Specialist
Location: Branchburg NJ 08876
Contract Period: 6 Months
Shift Timings: Mon - Fri 08:00 AM - 05:00 PM EST
6-month contract
- Process edit verify and route controlled documents within the electronic document management system.
- Documents include procedures forms specifications test methods and other quality system documents.
- This role works across multiple functions to ensure the appropriate level of document review and approval to build and maintain robust documentation.
- Reviews and evaluates low impact changes as Change Manager in the electronic Change Management System (OneTrack).
Education and Experience
- Bachelors degree and 3 years professional experience in Documentation/ Change Control or Associates Degree and 5 years of experience in Documentation/Change Control required.
- 5 years of experience in pharmaceutical/Medical Device industry preferred.
- Knowledge of computerized systems for document management preferably Veeva. Knowledge of Good Manufacturing Practices.
- Computer system knowledge of MS Office and TrackWise.
- Excellent verbal and written communication skills. Ability to work with multiple priorities with minimal supervision.
Must Haves:
- EDMS/eDMS
- Veeva Vault
- Document Control
- Change Management
- Change Control
- OneTrack
- MS Office