Carly O'rourke

Carly O'rourke

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Track and Trace, Serialization
United States

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Résumé


Jobs verified_user 0% verified
  • Eversana
    Serialization Analyst
    Eversana
    Dec 2023 - Current (2 years 8 months)
    • Works directly with clients, their customers and there CMOs with respect to Serialization integration for the support of DSCSA regulatory compliance. • Support of client and customer DSCSA implementation with the various EPCIS file formats.  Includes the generation and communication of test files and support of the move to production. • Resolution and communication of revised EPCIS files for the support of shipment variances that may arise. • Collabrates with the EDI team for the support of DSCSA electronic documents and ensure effective communication. • Support current day-to-day serialization activities and manage documentation of projects. • Coordinate with vendors and other technology teams to implement serialization project and analy
  • Resilience
    Serialization Technical Consultant
    Resilience
    Apr 2023 - Sep 2023 (6 months)
    • Conducted research to identify potential serialization solutions that meet the organization's needs and requirements at multiple sites. • Evaluated capabilities, features, and costs of each solution to determine the best fit for the organization. • Created URS, Architectural Blueprints and other documentation for the deployment and implementation of the solution. • Developed plans of action, remediation and assisted in hardware qualification and software validation activities working closely with global and local quality resource. • Developed plans of action for integrations with multiple serialization vendors including Optel, Systech, SAP and rfXcel. • Educated global and local personal on procedures and requirements for DSCSA compliance
  • A
    IT Serialization Analyst
    Akorn Pharmaceutical
    Jul 2021 - Feb 2023 (1 year 8 months)
    Responsible for supporting enterprise serialization capabilities in a pharmaceutical environment. Working closely with serialization and engineering support resources across multiple locations to provide application support & training. Provide oversight and direction of serialization processes to drive enterprise standardization across environments. Provide application and hardware lifecycle management and maintenance planning. Create and implement SOPs and training materials for serialization process. Show less
  • Akorn Pharmaceuticals
    Serialization analyst
    Akorn Pharmaceuticals
    Nov 2017 - Feb 2023 (5 years 4 months)
  • Akorn Pharmaceuticals
    Serialization Lead Technician
    Akorn Pharmaceuticals
    Jul 2017 - Jul 2021 (4 years 1 month)
  • VNS Health
    Business Service Coordinator
    VNS Health
    Jun 2013 - Jul 2017 (4 years 2 months)
  • C
    Project Coordinator/Executive Assistant
    Certified Multi Media Solutions
    Jun 2010 - Jan 2012 (1 year 8 months)
Education verified_user 0% verified
    This is a community-created genome.