Controlled Substance & Materials Compliance Specialist

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

Benefits offered by this job

401(k) plan

Health benefits

Dental and vision coverage

Paid time off

Job summary

Fresenius Kabi USA, LLC is seeking a Materials Management & Controlled Substance Specialist in Chicago, IL. The role oversees compliant lifecycle management and movement of development materials, including controlled substances, ensuring DEA and regulatory adherence.

You will collaborate across Quality, Regulatory Affairs, Supply Chain and Manufacturing to support secure handling, inventory control, and inspections. A 2+ year background in regulated materials and a Bachelor's degree is required.

Qualifications

• Bachelor’s degree in Science, Chemistry, Supply Chain, or related field.
• 2+ years of experience in materials management or regulated substances.
• Controlled substance recordkeeping & reporting experience.
• Proficiency in Microsoft Office applications.
• Excellent organizational, communication, and documentation skills.
• Strong understanding of regulatory and compliance requirements for pharma materials and controlled substances.
• Certification in DOT and IATA shipping procedures preferred.

Responsibilities

• Oversee receipt, quarantine, release, storage, dispensing, transfer, shipment, inventory control, and disposal of regulated materials in compliance with procedures and regulatory requirements.
• Support material lifecycle activities, including sampling, testing, inventory management, inter-site transfers, shipments, hazardous material transport, and customs clearance.
• Maintain inventories of reference standards, reserve samples, retention samples, qualification, issuance, and disposal activities.
• Manage controlled substance inventories, dispensing, reconciliation, recordkeeping, reporting, destruction, and physical security controls per DEA/state/company requirements.
• Maintain DEA registrations and state licenses, coordinate regulatory submissions, support inspections and audits, ensure inspection-ready documentation.
• Create and improve procedures, records, training, and controls supporting materials management and regulatory compliance programs.
• Collaborate cross-functionally with Quality, Regulatory, Supply Chain, Manufacturing, Legal, suppliers, and regulators.

Skills

Microsoft Office

Organizational skills

Documentation skills

Regulatory compliance

Education

Bachelor’s degree in Science or related field

Tools

Microsoft Office

Job description

Fresenius Kabi USA, LLC is seeking a Materials Management & Controlled Substance Specialist in Chicago, IL. The role oversees compliant lifecycle management and movement of development materials, including controlled substances, ensuring DEA and regulatory adherence.

You will collaborate across Quality, Regulatory Affairs, Supply Chain and Manufacturing to support secure handling, inventory control, and inspections. A 2+ year background in regulated materials and a Bachelor's degree is required.