The Opportunity: DSCSA/Serialization Data Analyst
As a DSCSA/Serialization Data Analyst, you will help our clients maintain high-quality serialization data, regulatory compliance, and full traceability from manufacturing to delivery. Your expertise will be integral in identifying and troubleshooting serialization data issues to ensure adherence with the DSCSA (Drug Supply Chain Security Act) and potentially other general regulations.
Key Responsibilities
• Monitor data quality and ensure compliance with DSCSA and global regulations.
• Maintain full traceability of units, cartons, cases, and pallets.
• Serve as the EPCIS data expert, troubleshooting reported data issues.
• Investigate and resolve serialization system discrepancies.
• Support system testing, validation, and upgrades.
• Respond to verification requests and proactively monitor systems daily.
• Assist in investigating negative responses to salable return verification requests.
• Maintain compliance documentation and serialization procedures.
What You Bring
Education & Experience
• Bachelor’s degree or equivalent.
• 3+ years of experience in serialization business processes.
• Life sciences, biotech, or regulated industry experience.
• Knowledge of Good Manufacturing Practice (GMP) & Good Documentation Practice (GDP).
• Experience with process improvement initiatives
Technical Skills
• Experience with Serialization Systems: TraceLink, Rfxcel, LSPEDIA, Systech, SAP ATTP, etc.
• Strong knowledge of GS1 Serialization Data Standards.
• Data analysis and problem-solving skills.
Soft Skills
• Strong interpersonal and communication skills.
• Ability to navigate complexity in a matrixed business environment.
• Action-oriented with attention to detail and accuracy.
• Ability to influence stakeholders and work collaboratively.
📌 Drug Supply Chain Security Act Analyst (Colombia)
🏢 Safeguard Global
📍 Colombia
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