Serialization IT Analyst

Job Summary

The Serialization IT Analyst coordinates the planning and implementation of the Drug Supply Chain Safety Act serialization system to align with business initiatives. Responsible for working with internal customers in identifying information opportunities and practical solutions using existing or new business systems technology. This role will define, scope, and develop or lead the development team to complete project needs within the ERP systems. This analyst will be responsible for Business to Business and internal system communications to provide extended functionalities to all departments of the business.

Position Responsibilities

• Maintain and support existing manufacturing IT systems.
• Partner with service providers and team members for platform and database support.
• Prepare & drive support agreements/SLAs with vendors & internal customers.
• Maintain system documentation for GxP critical IT systems.
• Responsible for change control & configuration management of systems.
• Ensure user training & user support is in place.
• Ensure data integrity & business/system continuity planning.
• Lead incident & problem investigations using Lean methodology & ensure quality deviations are remediated with appropriate effective corrective actions to ensure non-recurrence.
• Ensure system compliance with relevant internal SOPs & guidelines as well as external requirements (21CFR Part 11, Annex 11, Health Insurance Portability and Accountability Act (HIPAA), and SOX).
• Represent IT systems in connection with audits & inspections. May lead cross-functional project teams for process improvement.
• Ensure continued & improved overall user satisfaction with systems.
• Monitor serialization and "Track and Trace” regulatory requirements to ensure the company is compliant.
• Manage all data flow across different environments for serialization data, including GS1 standards for serialization.
• Enable seamless operation of Track and Trace serialization systems.
• Collaborate with external Supply Chain partners (CMO's, 3PLs, Wholesalers, Distributors, Customers) for real time visibility to support serialization activities.
• Assist in technical problem solving to resolve technical and compliance issues and propose process improvements to streamline operations.
• Provide support for packaging and labeling product security initiatives globally. Collaborate on qualification protocols for appropriate test design and execution.
• Monitor serialization and track and trace regulatory requirements ensuring the company's compliance.
• Monitor and provide technical support for L4/L5 Serialization systems (Tracelink).
• Collaborate with Supply Chain team to enable new partner and product set up in ERP/MDM/Serialization system.
• Investigate and verify negative responses to salable return verification requests.

Skills

• Excellent verbal and written communication.
• Self-motivated with a focus on driving results and strong sense of accountability

Education / Experience:

• Bachelor's degree or relevant experience.
• Five to ten years related experience.
• Ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.
• Ability to consult with stakeholders to define required changes to align system functionality with business needs.
• Proficiency with serialization solutions including Tracelink, Verify Platform, Optel, ACG.
• Performs tasks utilizing excellent written and verbal communication skills.
• Must be able to work with a diverse variety of people.
• 5 years or more in Track and Trace/Serialization.
• 5 years or more in IT, Manufacturing and Supply chain background.
• Ability to read/write EPCIS(XML) files and understanding of GS1 standards.
• In-depth knowledge of the Drug Supply Chain Security Act (DSCSA).
• Experience with Tracelink L4 systems preferred.
• Experience or Working Knowledge of Optel L1-L3 systems preferred.
• Experience or Working Knowledge with ACG L1-L3 systems preferred.