Newark Metro Area, NJ
QA documentation updates, information and records management, Project Coordinator for GMP Engineering
- . Draft, revise, review route and approve Standard Operating Procedures, Work Practices, Forms, and other type of GMP documentation deliverables.
- Responsible for routing document deliverables through the Document Management system.
- May assist with writing deviations, CAPAs, Change Controls.
- Facilitate periodic reviews of SOPs.
- Keeps a log of documents and their states, including types, owner, reviewers, due dates, etc.
- Follows up with team members and cross functional team members to encourage timely review and approval.
- Promotes and provides excellent customer service and support
- Regularly reviews, prioritizes and promptly responds to customer equipment maintenance, repair and support requests.
- Provides technical support and guidance on calibration and maintenance issues. Interfaces with customers to ensure expectations are being met.
- Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
BS/or AA degree with experience. Combination of education and practical experience
Minimum 5 years of Facilities/maintenance/engineering project coordinating / planning experience, preferably in a biotech environment.