Materials & Controlled Substances Compliance Lead

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

Benefits offered by this job

401(k) with company contributions

Paid vacation, holidays, and personal/

Health benefits: medical, dental, and视

Job summary

Fresenius Kabi USA seeks a Materials Management & Controlled Substance Specialist to oversee the compliant lifecycle and movement of development materials, including APIs and regulated substances. Serves as SNSR to ensure DEA compliance, documentation, storage, and inspections in a heavily regulated environment.

The role involves coordinating sampling, testing, inventory, inter-site transfers, shipments, and regulatory submissions while collaborating across Quality, Regulatory, and Supply Chain

Qualifications

• Bachelor's degree or higher in science, chemistry, supply chain or related field.
• 2+ years of experience in materials management or controlled substances environment.
• Controlled substance recordkeeping & reporting experience.
• Proficiency in Microsoft Office applications.
• Excellent organizational, communication, and documentation skills.
• Strong understanding of regulatory and compliance requirements for pharmaceutical materials and controlled substances.
• DOT and IATA shipping procedures certification preferred.
• English language proficiency required to perform essential functions.

Responsibilities

• Oversee receipt, quarantine, release, storage, dispensing, transfer, shipment, inventory control and disposal of raw materials, APIs, excipients, reference standards, and other regulated materials in compliance with procedures and regulatory requirements.
• Coordinate material supply and logistics operations including sampling, testing, inventory management, inter-site transfers, domestic/international shipments, hazardous materials transport, customs clearance, and ensuring material availability for development and manufacturing.
• Administer reference standard and sample management programs including inventories, retention samples, qualification, issuance, reconciliation, storage monitoring and disposal activities.
• Ensure controlled substance compliance and accountability through inventories, dispensing, reconciliation, recordkeeping, reporting, destruction activities and physical security controls per DEA/state/company requirements.
• Support regulatory licensing, reporting, and inspection readiness by maintaining registrations, coordinating submissions, supporting inspections and audits, and ensuring inspection-ready documentation.
• Develop and maintain compliance systems and procedures supporting materials management and regulatory programs.
• Collaborate cross-functionally with Quality, Regulatory Affairs, Supply Chain, Manufacturing, Legal, and external partners to ensure compliant operations.
• Perform additional responsibilities and special projects as assigned.

Skills

Regulatory compliance

Attention to detail

Documentation

English proficiency

Education

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

Tools

Microsoft Office

Job description

Fresenius Kabi USA seeks a Materials Management & Controlled Substance Specialist to oversee the compliant lifecycle and movement of development materials, including APIs and regulated substances. Serves as SNSR to ensure DEA compliance, documentation, storage, and inspections in a heavily regulated environment.

The role involves coordinating sampling, testing, inventory, inter-site transfers, shipments, and regulatory submissions while collaborating across Quality, Regulatory, and Supply Chain