Serialization Associate

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

What We're Looking For

▸ Required Qualifications

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 fo