Supply Chain Traceability

As a key member of the team, you will be responsible for supporting daily DSCSA operations, which include product serialization, traceability, and exception handling. Your role will involve coordinating with internal teams such as QA, IT, Logistics, as well as external partners like CMOs, 3PLs, and wholesalers to ensure accurate product data exchange. In this position, you will play a crucial role in monitoring and investigating DSCSA compliance issues, such as "data no product" and "product no data" exceptions. You will also be responsible for ensuring the accurate and timely submission of T3 data, which includes Transaction Information, Transaction History, and Transaction Statement. A significant part of your responsibilities will include reconciling all outbound shipments from the 3PL using the middleware system to guarantee compliance with DSCSA guidelines. Additionally, you will need to maintain records of DSCSA-related activities in compliance with FDA regulations. You will also provide support in system testing, documentation, and implementation of serialization and verification solutions, such as EPCIS and VRS. It will be essential for you to stay updated on evolving FDA DSCSA regulations and industry best practices to ensure compliance. As part of your role, you will participate in audits, inspections, and readiness exercises to contribute to the overall compliance efforts of the organization. Your attention to detail, ability to collaborate with cross-functional teams, and commitment to staying informed on regulatory changes will be critical to success in this position.,