Associate - Supply Chain Traceability

Job Description :

• Support daily DSCSA operations including product serialization, traceability, and exception handling.
• Coordinate with internal teams (QA, IT, Logistics) and external partners (CMOs, 3PLs, wholesalers) to ensure accurate product data exchange.
• Monitor and investigate DSCSA compliance issues such as "data no product" and "product no data" exceptions.
• Ensure accurate and timely submission of T3 data (Transaction Information, Transaction History, and Transaction Statement).
• Reconcile all outbound shipments from the 3PL using the middleware system to ensure compliance with DSCSA guidelines.
• Maintain records of DSCSA-related activities in compliance with FDA regulations.
• Assist with system testing, documentation, and implementation of serialization and verification solutions (e.g., EPCIS, VRS).
• Stay updated on evolving FDA DSCSA regulations and industry best practices.
• Participate in audits, inspections, and readiness exercises.