Operations Information Analyst
Application Deadline: April 30, 2020
Location: Schaumburg , IL, USA
Sagent Pharmaceuticals - Schaumburg, IL
Operations Information Analyst
Sagent Pharmaceuticals is expanding its Supply Chain team and we are looking for a YOU! If you are a unique blend of Supply Chain, Business Analyst and advanced Excel, this is the role for you. This position is responsible for supporting the data management and transactional exchange of data supporting Sagent’s pharmaceutical supply chain network and ensures data is accurately and efficiently maintained.
Day to day:
- Supports the serialization initiatives to stay compliant with DSCSA and other product identification related regulations within the US.
- Ensure daily activities are running successfully and assist in the management of validation project interfaces / interactions
- Support serialization-related activities for new product launches, commercial manufacturing, on-boarding new Partners, implementing new processes, maintaining existing processes, and manage serialization related systems such as TraceLink
- Supports Sagent’s changing regulatory landscapes target markets and support opportunities to leverage data and serialized information for better visibility and tracking
- Interface with various internal functions, internal manufacturing, contract manufacturing organization (CMO), contract packaging organization (CPO), third party logistics (3PL), and downstream partners to support data integrity and corporate efforts for serialization compliance throughout the process life cycle
Operations Information Analyst will be expected to:
- 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, Supply Sources (i.e. CMOs, CPOs, internal Manufacturing sites), 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 system
- 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
- Have experience with Business Analysis, Manufacturing or Supply Chain experience
- Knowledge of Serialization / Drug Supply Chain Security Act (DSCSA) / Track and Trace requirements
- Knowledge of GS1 Standards, EPCIS, HDA Standards (preferred)
- Associates Degree required with 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)
HOW TO APPLY
All resumes should be forwarded to email@example.com
- What is the candidate’s experience in supply chain in a FDA regulated environment?
- What is your experience with Excel and ERP Systems?
- What are your salary expectations?
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.