Job Summary:

The Senior Quality Specialist will be part of the Quality Assurance Department and will support Supplier Management activities at the Ridgefield site. This role is responsible for managing supplier-related quality processes, including Third-Party Change Notifications (TPCN), supplier corrective actions, and supplier qualification activities, while ensuring compliance with applicable GMP and regulatory requirements.

Key Responsibilities:

• Manage the site's Third-Party Change Notification (TPCN) process, including logging, triaging, assignment, and determination of change criticality.


• Track TPCN activities to completion and prepare presentations for monthly review meetings.


• Review and approve third-party investigation reports related to supplier complaints and Supplier Corrective Action Reports (SCARs).


• Maintain and support the Supplier Qualification Program for both n...