Job Description

The DSCSA Inventory & Discrepancy Investigation Coordinator is responsible for coordinating and overseeing investigations of inventory and shipment discrepancies identified internally or reported by customers, while performing investigation activities related to DSCSA, serialization, and product traceability. The position serves as the central point of coordination among Quality Assurance, Inventory Management, DSCSA, Warehouse Operations, Order Operations, Transportation, Security, DEA Compliance, IT, and other applicable departments to ensure required investigation activities are assigned, completed, and documented in accordance with established procedures. The Coordinator monitors investigation progress, facilitates cross-functional communication and follow-up, ensures supporting documentation and findings are maintained in the investigation record, identifies outstanding actions, and coordinates investigations through reconciliation and closure.

Essential Functions:

• Coordinates cross-functional investigations of inventory and shipment discrepancies identified internally or reported by customers. Serves as the central point of coordination among applicable departments, ensures required investigation activities are assigned to the appropriate functions, monitors progress and due dates, identifies outstanding actions, facilitates follow-up, and escalates unresolved or time-sensitive issues as appropriate.
• Supports root-cause analysis, corrective/preventive actions, and continuous-improvement activities associated with recurring inventory, shipment, serialization, or traceability discrepancies. Recommends improvements to investigation workflows, documentation practices, procedures, work instructions, and controls designed to improve inventory accuracy, product traceability, and discrepancy prevention.
• Maintains complete and organized investigation records. Ensures supporting documentation, departmental findings, system research, correspondence, and other relevant evidence are captured in the investigation record. Reviews investigations for completeness, follows up on missing information or open actions, and coordinates documentation of findings, reconciliation, disposition, and closure in accordance with established procedures.
• Performs investigation activities related to DSCSA, serialization, and product traceability. Researches applicable serialized product and transaction information, including product identifiers, lot and serial data, SSCC information, shipment history, and other available traceability records. Coordinates with DSCSA, Quality, IT, trading partners, and other subject-matter experts when additional technical or compliance review is required.
• Tracks investigation status, aging, volume, discrepancy types, and recurring issues. Provides clear updates to the Business Process Manager and applicable stakeholders, identifies trends or systemic concerns, and supports development of reports, trackers, dashboards, or other tools used to improve investigation visibility and accountability.

Additional Responsibilities:

• Provide support to Business Process Coordinators, as needed, with product destruction activities, customer setup and onboarding, day-to-day logistics and distribution functions as related to serialization, and other DSCSA and traceability related activities.
• Performs other functions as required or assigned.
• Complies with all company policies, standards, SOPs, and applicable GMP requirements.

Education:

• Associate Degree Logistics, Supply Chain, Business, Quality, Information Systems, Pharmaceutical Sciences, or related field - Preferred

Experience:

• 3 years or more in Pharmaceutical distribution, warehouse operations, inventory management, supply chain, serialization, DSCSA, quality, or related regulated operational experience.
• 1 year or more in Experience investigating inventory, order, shipment, serialization, product traceability, or related discrepancies and coordinating activities across multiple functions.
• less than one year in Experience with ERP/WMS, serialization, traceability, investigation-management, or related enterprise systems.

Specialized Knowledge:

• Working knowledge of pharmaceutical warehouse and distribution operations, including receiving, inventory management, picking, packing, shipping, and inventory reconciliation.
• Working knowledge of DSCSA requirements, pharmaceutical serialization, and product traceability concepts.
• Understanding of serialized product identifiers and hierarchical relationships, including NDC/GTIN, serial number, lot number, expiration date, and SSCC.
• Knowledge of investigation practices, discrepancy reconciliation, root-cause analysis, documentation requirements, and corrective/preventive action concepts.
• Knowledge of GMP/SOP-controlled environments and Good Documentation Practices is preferred; proficiency with Microsoft Office and experience with ERP/WMS, serialization, traceability, or investigation systems is also preferred.