Materials Management Specialist Fresenius Kabi USA
Overview
The Materials Management Specialist leads the compliant lifecycle management of development materials and controlled substances at our Chicago site. This role ensures adherence to DEA regulations while partnering cross-functionally to support secure handling of APIs and regulated materials. The successful candidate will serve as the Site Narcotic Substance Responsible person focusing on full compliance with controlled substance handling documentation and inspections.
What You'll Do7
- 1Manage the Materials Management Program overseeing receipt quarantine release storage dispensing transfer shipment inventory control and disposal of raw materials APIs excipients reference standards RLD materials and other regulated materials
- 2Coordinate Material Supply and Logistics Operations supporting material lifecycle activities including sampling testing inventory management inter-site transfers domestic and international shipments hazardous material transportation customs clearance and material availability for development and manufacturing
- 3Administer Reference Standard and Sample Management Programs maintaining inventories of regulatory and non-regulatory reference standards reserve samples and retention samples through qualification issuance reconciliation storage monitoring periodic inventories and disposal
- 4Ensure Controlled Substance Compliance and Accountability managing controlled substance inventories dispensing reconciliation recordkeeping reporting destruction activities and physical security controls per DEA state and company requirements
- 5Support Regulatory Licensing Reporting and Inspection Readiness maintaining DEA registrations and state licenses coordinating regulatory submissions supporting inspections and audits maintaining inspection-ready documentation and ensuring ongoing compliance
- 6Develop and Maintain Compliance Systems and Procedures creating reviewing implementing and continuously improving processes records training and operational controls for materials management controlled substance management and regulatory compliance
- 7Collaborate Cross-Functionally to Support Business Operations partnering with Quality Regulatory Affairs Supply Chain Manufacturing Legal Corporate Services external suppliers laboratories and regulatory agencies to ensure compliant and efficient management of materials and controlled substances
Requirements6
- 1Bachelor’s degree in Science Chemistry Supply Chain or related field
- 22+ years of experience with controlled substance recordkeeping and reporting
- 3Proficiency in Microsoft Office applications
- 4Excellent organizational communication and documentation skills
- 5Strong understanding of regulatory and compliance requirements related to pharmaceutical materials and controlled substances
- 6Certification in DOT and IATA shipping procedures preferred
Salary Insight
$70 - $75k per year
Location
Required Skills
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