Materials & Controlled Substances Compliance Specialist

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

Benefits offered by this job

401(k) plan with company contributions

Health benefits package

Paid time off

Job summary

Fresenius Kabi USA, LLC seeks a Materials Management & Controlled Substance Specialist to oversee compliant lifecycle management and movement of development materials, including APIs and controlled substances, ensuring DEA and regulatory adherence.

The role partners with Quality, Regulatory Affairs, Supply Chain, and Manufacturing to support secure handling, documentation, and inspection readiness, serving as SNSR, with responsibilities across receiving, storage, dispensing, and distribution.

Qualifications

• 2+ years of experience in materials management or regulated substances
• Strong knowledge of regulatory and DEA requirements for controlled substances
• Experience with recordkeeping, reporting, and compliance documentation
• Proficiency with Microsoft Office applications and data management systems
• Ability to effectively communicate and document procedures and policies

Responsibilities

• Oversee receipt, quarantine, release, storage, dispensing, transfer, shipment, inventory control, and disposal of materials in compliance with procedures and regulations
• Coordinate material supply and logistics including sampling, testing, inventory management, inter-site transfers, and regulatory shipments
• Administer reference standards and sample management programs with proper qualification, issuance, and disposal
• Manage controlled substance inventories, reconciliation, reporting, and security controls per DEA and state requirements
• Support regulatory licensing, registrations, inspections, and audit readiness with accurate documentation
• Develop and maintain compliant procedures and training materials
• Collaborate with Quality, Regulatory Affairs, Supply Chain, Manufacturing, Legal, and external partners to ensure compliant operations

Skills

Microsoft Office

Regulatory compliance

Documentation skills

Communication skills

English proficiency

Education

Bachelor's degree in Science or related field

Tools

Microsoft Office Suite

Job description

Fresenius Kabi USA, LLC seeks a Materials Management & Controlled Substance Specialist to oversee compliant lifecycle management and movement of development materials, including APIs and controlled substances, ensuring DEA and regulatory adherence.

The role partners with Quality, Regulatory Affairs, Supply Chain, and Manufacturing to support secure handling, documentation, and inspection readiness, serving as SNSR, with responsibilities across receiving, storage, dispensing, and distribution.