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Supply Chain Business Analyst

Application Deadline: August 17, 2019

Location: SCHAUMBURG, IL, USA

Job Summary / Overview:

Support Sagent’s compliance and integration of Sagent’s 3PL, Supply Sources, TraceLink (Track and Trace Solution), and Sagent’s downstream partners to ensure Sagent is compliant with Serialization and Track and Trace requirements. Support and assist in driving project plans and associated timelines for Serialization Readiness while supporting the management needs of lot level traceability requirements and partner onboarding. Ensure day to day activities are running efficiently and assist in the management of validation project interfaces / interactions.

Job Summary / Overview:

Support Sagent’s compliance and integration of Sagent’s 3PL, Supply Sources, TraceLink (Track and Trace Solution), and Sagent’s downstream partners to ensure Sagent is compliant with Serialization and Track and Trace requirements. Support and assist in driving project plans and associated timelines for Serialization Readiness while supporting the management needs of lot level traceability requirements and partner onboarding. Ensure day to day activities are running efficiently and assist in the management of validation project interfaces / interactions.

Assist with project tasks to ensure alignment, collaboration and coordination across internal/external functional areas throughout the implementation process. Ability to identify gaps or assist in resolving gaps in process to ensure Sagent company maintains lot level traceability requirements and further support on the readiness for Serialization. This role will support initiatives to drive compliance, foster collaborative and cross-functional relationships, and provide analytical support.

Key Duties & Responsibilities:



    • Interface with 3PL, Supply Sources, TraceLink and Trading Partners to manage daily responsibilities, communications, and continuing integrations

    • Maintain 3PL and TraceLink systems with respect to Serialization and Track and Trace requirements





  • Support departmental investigation needs, inclusive but not limited to suspect and / or illegitimate product


 



    • Daily system review and reconciliation of data exchange activities

    • Assist with ad hoc projects, data analysis and reporting as needed to support key business initiatives

    • Maintain and manage partner and product master data, conduct needed analysis to ensure data integrity is maintained

    • Onboard and maintenance of associated master data for direct customers, CMOs, manufacturing facilities, and other associated upstream and downstream partners to the TraceLink system

    • Determine and document processes, work instructions, and SOPs impacted by department

    • Support and development of various processes related to system data exchange

    • Support business activities associated to the Track and Trace process for both upstream and downstream partners





  • Gain understanding of user and systems requirements and high level understanding of the process and system design


 

  • Create test plans and test cases to complete Performance Qualification of updates to TraceLink system

  • Prepare for implementation of Serialization for Track and Trace compliance by supporting and assist to drive process changes to ensure execution of Serialization deadlines

  • Strong sense of urgency, including the ability to meet or exceed deadlines and set priorities

  • Strong quantitative, analytical, problem solving and conceptual skills

  • Provide status report to communicate issues, exceptions, and progress as required


Knowledge or Experience:

  • Strong analytical, organizational, team and project skills



  • Strong computer and problem solving skills

  • Ability to successfully handle multiple, competing priorities in a fast-paced, changing team environment



  • Ability to facilitate discussions and know when to escalate

  • Demonstrated capabilities with system validation and/or user acceptance testing (UAT)



  • Knowledge of Production, Supply Chain, Logistics and/or other core functions, preferably within Pharmaceutical Supply Chain

  • Knowledge of IT Integration/Business Analyst functions – Strongly Preferred

  • Knowledge of Serialization / Drug Supply Chain Security Act (DSCSA) / Track and Trace requirements – Strongly Preferred

  • Regulatory and/or Quality experience a plus


Minimum Qualifications / Experience:

  • 3 or more years of Supply Chain and/or Business Analyst responsibilities

  • Strength at troubleshooting and problem solving with data analysis skills

  • Strong communication skills, both written and verbal


Education / Certifications:

Associate degree required, Bachelor preferred
Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.

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