Change Control Coordinator - Entry Level

About the role

Average weekly hours: 40.00
Shift: 1st Shift
Employment type: Contract on W2 (US Citizens or GC Holders only)

Responsibilities

• Reviews and analyzes proposed changes to controlled documentation
• Verifies references and standards are current and active
• Ensures documentation meets all local, segment, and corporate requirements
• Implement documentation and change control using the electronic documentation and change control software
• Programs/software used include; JD Edwards, Master Control, Microsoft Word, Access, Excel, Microsoft Teams, and One Drive
• May participate in FDA, Corporate, and internal audits
• Data analysis and system report running

Requirements

• Experience in a documentation related position preferably in an FDA and/or regulated environment
• Experience in Electronic Document Management System software, Master control is preferred
• Medical Device Industry experience a plus
• Experience in a regulated environment preferred, such as FDA, ISO.. etc.
• Minimum of an Associate’s Degree, Bachelor's degree highly preferred