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QA Specialist

Newark Metro Area, NJ

Posted: 08/07/2018 Job Type: Scientific Job Number: JN -082018-22250
QA documentation updates, information and records management, Project Coordinator for GMP Engineering

Essential Functions:
  • . 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.
Education & Experience:

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.

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