DEA Compliance & Materials Management Specialist

Fresenius Kabi USA; Chicago (IL); On-site; USD 70,000 - 75,000; Full time

Benefits offered by this job

401(k) with company contributions

Paid vacation; holidays; personal days

Health benefits (medical, dental, and视

Job summary

Fresenius Kabi USA seeks a Materials Management & Controlled Substance Specialist to oversee compliant lifecycle management of development materials, including controlled substances. As SNSR, ensure DEA compliance and inspections, handling receiving, storage, dispensing, and distribution.

Salary range $70,000 - $75,000 with a comprehensive benefits package. Opportunities to collaborate cross-functionally with Quality, Regulatory Affairs, Supply Chain, and Manufacturing.

Qualifications

• Bachelor’s degree in Science, Chemistry, or related field.
• 2+ years of experience
• Controlled substance recordkeeping & reporting experience
• Proficiency in Microsoft Office applications
• Excellent organizational, communication, and documentation skills
• Strong understanding of regulatory and compliance requirements related to pharmaceutical materials and controlled substances
• Certification in DOT and IATA shipping procedures preferred
• The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Responsibilities

• Manages the Materials Management Program by overseeing the receipt, quarantine, release, storage, dispensing, transfer, shipment, inventory control, and disposal of raw materials, APIs, excipients, reference standards, RLD materials, and other regulated materials in compliance with company procedures and regulatory requirements.
• Coordinate Material Supply and Logistics Operations by 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 activities.
• Administer Reference Standard and Sample Management Programs by maintaining inventories of regulatory and non-regulatory reference standards, reserve samples, and retention samples, including qualification, issuance, reconciliation, storage monitoring, periodic inventories, and disposal activities
• Ensure Controlled Substance Compliance and Accountability by managing controlled substance inventories, dispensing, reconciliation, recordkeeping, reporting, destruction activities, and physical security controls in accordance with DEA, state, and company requirements.
• Support Regulatory Licensing, Reporting, and Inspection Readiness by maintaining DEA registrations and state licenses, coordinating required regulatory submissions, supporting inspections and audits, maintaining inspection-ready documentation, and ensuring ongoing compliance with applicable regulations.
• Develop and Maintain Compliance Systems and Procedures by creating, reviewing, implementing, and continuously improving procedures, records, training, and operational controls that support materials management, controlled substance management, and regulatory compliance programs.
• Collaborate Cross-Functionally to Support Business Operations by 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.
• Perform additional responsibilities and special projects as assigned.

Skills

Controlled substances

DEA compliance

Regulatory docs

Microsoft Office

Attention to detail

Communication skills

English proficiency

Education

Bachelor’s degree in Science, Chemistry, Supply Chain, or related field

Job description

Fresenius Kabi USA seeks a Materials Management & Controlled Substance Specialist to oversee compliant lifecycle management of development materials, including controlled substances. As SNSR, ensure DEA compliance and inspections, handling receiving, storage, dispensing, and distribution.

Salary range $70,000 - $75,000 with a comprehensive benefits package. Opportunities to collaborate cross-functionally with Quality, Regulatory Affairs, Supply Chain, and Manufacturing.