IT Project Coordinator

5 days onsite, $100.72/hr

Job Summary

We are looking for a IT Project Coordinator for our very important client. Our client is a leader in the life science industry. As an IT Project Coordinator, you will manage change records and support ongoing product lifecycle activities for combination products. You’ll collaborate with cross-functional teams, manufacturing sites, and external partners to ensure changes are executed efficiently and in compliance with global regulatory standards.

Key Responsibilities

• Manage combination product change control records
• Initiate, route, and close change records for product and manufacturing process updates
• Support changes related to design and development, including design control documentation
• Coordinate implementation across multiple manufacturing sites and ensure timely closure of records
• Coordinate post-market surveillance and risk management activities:
• Compile and analyze surveillance data for annual reporting
• Generate yearly risk summaries and maintain risk management files
• Support complaint investigations and documentation
• Act as a central point of contact across cross-functional teams to ensure supply continuity
• Partner with vendors, suppliers, and contract manufacturers to execute and track changes

Requirements

• Bachelor’s degree (BS or BA)
• 3–5 years of relevant experience in a related field
• Experience working in medical device development and/or pharmaceutical operations within a cGMP environment
• Understanding of change control processes in a regulated industry
• Strong project management, organizational, and time management skills
• Familiarity with US, EU, and international medical device and pharmaceutical regulations
• Experience with Veeva Vault