Serialization Associate (DSCSA / EPCIS / TraceLink)

Requirements

• Experience supporting a pharmaceutical 3PL or wholesaler (McKesson, AmerisourceBergen, Cardinal) in a serialization capacity
• Exposure to WMS platforms (SAP WM/EWM or similar) and their interaction with serialization systems
• Understanding of DSCSA Section 582(d) 3PL-specific obligations
• GS1 Healthcare or DSCSA-related certification
• ITIL-based service management experience
• OUR CULTURAL BELIEFS:
• Patient Minded I act with the patient's best interest in mind.
• Client Delight I own every client experience and its impact on results.
• Take Action I am empowered and empower others to act now.
• Grow Talent I own my development and invest in the development of others.
• Win Together I passionately connect with anyone, anywhere, anytime to achieve results.
• Communication Matters I speak up to create transparent, thoughtful and timely dialogue.
• Embrace Diversity I create an environment of awareness and respect.
• Always Innovate I am bold and creative in everything I do.

Benefits

Additional Information

As a Serialization Associate, you will serve as a front-line execution specialist responsible for investigating, resolving, and documenting DSCSA compliance exceptions across our pharmaceutical 3PL client portfolio. Working in a fast-paced, 24x6 support environment, you will own ticket resolution from triage to closure - ensuring serialization events are accurate, compliant, and fully traceable. DSCSA Transaction & Exception Handling Investigate and resolve EPCIS file failures including schema errors, master data mismatches, and event sequence violations Validate commission events, aggregation hierarchies (SSCC to Case to Each), shipping/receiving confirmations, and returns verification events Review inbound and outbound EPCIS transactions for accuracy prior to retransmission Identify and correct mismatches in SGTIN/SSCC, GLN/SGLN, lot/expiry data, and business step inconsistencies Document all exceptions and resolutions in ServiceNow with sufficient detail for audit purposes Serialization Lifecycle Execution Apply working knowledge of the full DSCSA event lifecycle: Commission, Pack/Aggregate, Ship, Receive, Return, and Destroy Validate aggregation integrity before authorizing outbound shipment events Troubleshoot serialized returns and product status discrepancies across trading partners Support reprocessing and retrigger strategies for failed or rejected events Platform & Repository Troubleshooting (L4 Systems) Work within serialization platforms including TraceLink, rfxcel, and Systech Identify and resolve common repository rejections: duplicate commissioning, invalid aggregation structures, missing transaction identifiers Collaborate with senior team members on complex platform-level issues requiring configuration review Regulatory Compliance Awareness Maintain working knowledge of DSCSA Section 582 requirements, product tracing/verification obligations, and serialized returns saleable verification workflows Understand suspect/illegitimate product investigation triggers and escalation protocols Ensure all activities align with GS1 standards and DSCSA regulatory requirements Operational Excellence & Ticket Management Respond to assigned tickets within defined SLAs - no silent aging Maintain full incident ownership through resolution with structured handoff documentation Escalate systemic trends, recurring failure patterns, or compliance-at-risk items to the Project Leader Participate in shift handoffs with concise, structured status communication MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: 1-2 years of experience in pharmaceutical serialization, DSCSA operations, or supply chain compliance Hands-on experience with EPCIS file formats and GS1 standards (SGTIN, SSCC, GLN, BizStep) Familiarity with serialization platforms such as TraceLink, rfxcel, Systech, or SAP ATTP Experience in ITSM environments - ServiceNow preferred Strong analytical skills with close attention to regulatory detail Effective written communication for cross-functional audiences Ability to work on US Central Time shift

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