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Operations Information Analyst, Supply Chain

3 months ago

Schaumburg, United States Sagent Pharmaceuticals Full time
Job DescriptionJob Description

Sagent Pharmaceuticals - Schaumburg, IL

Operations Information Analyst, Supply Chain

Sagent Pharmaceuticals, founded in 2006, was built to focus on customer needs. At Sagent, we believe that excellence is our standard, our motivation and our guide. We believe the measure of success is determined by our customers, as we are a customer-focused company, delivering an extensive portfolio of injectable products and fulfilling the evolving needs of the patients we serve through our unique network of global resources.

The Operations Information Analyst supports Sagent’s serialization initiatives to ensure compliance with DSCSA and other regulations within the US. They ensure daily activities are running successfully and assist in the management of validation project interfaces / interactions. This role supports serialization-related activities for new product launches, commercial manufacturing, on-boarding new partners, implementing processes improvements, and managing serialization related systems such as TraceLink. They will support Sagent’s changing regulatory landscapes and create opportunities to leverage data and serialized information for better visibility and tracking.

This Analyst will interface with various internal functions and external organizations, including contract manufacturing organizations (CMOs), contract packaging organizations (CPOs), third party logistics (3PLs), and downstream partners to support data integrity and corporate efforts for serialization compliance throughout the process life cycle.

Key Duties and Responsibilities

  • Conduct routine audits on data management specifications (BOM’s, routings, planning parameters, etc.)
  • Maintain master data and data integrity.
  • Understand and support DSCSA related guidance and Sagent’s deployed serialization solution.
  • Support business activities associated to the Track and Trace process.
  • Interface and support Track and Trace related events with 3PL, CMOs, Trading Partners, and TraceLink to manage daily responsibilities, communications, and continuing integrations.
  • Daily system review and reconciliation of data exchange activities.
  • Document processes, guidelines, and SOPs impacted by department.
  • Support opportunities and efforts to improve processes through continuous improvement and business process re-engineering.
  • Support the integration and validation of interfaces with various partners (CMOs, 3PLs, Distributors, collaboration partners, internal departments) and systems.
  • Understand user and system requirements, and a high-level understanding of the process and system design.
  • Create risk assessments and appropriately test to support Performance Qualification of updates to Track and Trace supported systems.
  • Support departmental investigation needs, inclusive but not limited to enhanced verification and suspect and / or illegitimate product.
  • Provide status report to communicate issues, exceptions, and progress as required.

Candidate Qualifications:

  • Bachelor Degree and a minimum of 3 years in a Supply Chain or Business Analyst position
  • Proficient in MS Office, with strong experience in Excel functions including Pivot Tables and Formulas
  • Preferred experience with JDE or related ERP systems, TrackWise, TraceLink and FDA Regulated Industry
  • Demonstrated capabilities with system validation and/or user acceptance testing (UAT) (is a plus)
  • 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.
  • Have experience with Business Analysis, Manufacturing or Supply Chain.
  • Knowledge of Serialization / Drug Supply Chain Security Act (DSCSA) / Track and Trace requirements.
  • Knowledge of GS1 Standards, EPCIS, HDA Standards (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.