Serialization Specialist
Listed on 2026-02-06
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IT/Tech
IT Support, IT Business Analyst
Serialization & Traceability Compliance Specialist(DSCSA)
Job Summary
The Serialization & Traceability Compliance Specialist is responsible for monitoring, investigating, and resolving serialization and traceability exceptions in compliance with the Drug Supply Chain Security Act (DSCSA). This role supports enterprise exception management activities, ensures regulatory adherence, and partners with internal teams and external trading partners to maintain product integrity across the supply chain.
Key Responsibilities- Monitor, troubleshoot, and resolve serialization and traceability exceptions using the Trace Link SCWM platform or similar DSCSA systems.
- Investigate verification failures and traceability discrepancies, coordinating resolution and escalation with trading partners as needed.
- Support the development, implementation, and maintenance of SOPs and compliance workflows related to DSCSA exception handling.
- Maintain accurate compliance documentation and knowledge management records in alignment with internal policies and regulatory standards.
- Act as a liaison between internal teams and external trading partners, including manufacturers and wholesalers, to resolve quarantined inventory and exception-related issues.
- Assist with training for retail pharmacies, distribution centers, PBM mail, PBM specialty, and other business units on serialization compliance, exception management, and best practices.
- Support the ongoing enhancement of systems, tools, and processes used for high-volume exception management.
- Stay current on DSCSA regulatory requirements and milestones and provide input on process improvements and compliance readiness.
- Strong verbal and written communication skills with the ability to present findings and influence key stakeholders.
- Advanced analytical and problem-solving skills, with the ability to make data-driven decisions under regulatory timelines.
- Proven experience working cross-functionally and building consensus across large organizations.
- Ability to adapt quickly to shifting priorities and evolving DSCSA regulatory requirements.
- High attention to detail with a strong focus on accuracy, completeness, and documentation integrity.
- Demonstrated ability to manage complex work and competing priorities under tight deadlines.
- Experience in exception management, triage workflows, and issue resolution within high-volume, time-sensitive environments.
- Working knowledge of DSCSA serialization and traceability requirements across distribution center, PBM, and retail pharmacy environments.
- Understanding of pharmacy and warehouse product flow and operational processes.
- Hands-on experience with Trace Link or comparable DSCSA compliance platforms.
- Proven ability to manage queues, improve workflows, and drive process improvements across large organizations.
- Ability to influence outcomes and guide teams to resolution in high-stakes regulatory environments.
- Advanced proficiency in Microsoft Excel and PowerPoint.
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- Los Angeles City Fair Chance Ordinance
- Los Angeles County Fair Chance Ordinance for Employers
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