Location
Ridgefield, New Jersey
Job Type
Full-time
Posted
May 16, 2026
Job Description
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:
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...
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