Controlled Substances & Materials Compliance Specialist

Fresenius SE & Co. KGaA; Melrose Park (IL); On-site; USD 70,000 - 75,000; Full time

Job summary

Fresenius Kabi in Melrose Park is seeking a Materials Management & Controlled Substance Specialist to oversee compliant lifecycle management of development materials, including APIs and regulated substances, ensuring DEA and regulatory adherence.

You will manage receiving, storage, dispensing, transfers, and disposal, serve as SNSR, and collaborate with Quality, Regulatory Affairs, Supply Chain, and regulatory agencies to maintain inspection readiness and ongoing compliance.

Qualifications

• Requires a bachelor's degree in science or related field.
• Minimum 2 years of experience in materials management or regulatory compliance.
• Experience with controlled substances recordkeeping & reporting.
• Proficient with Microsoft Office applications.
• Strong organizational, communication, and documentation skills.
• Solid understanding of regulatory and compliance requirements related to pharmaceutical materials and controlled substances.
• DOT and IATA shipping certification preferred.

Responsibilities

• Oversee the receipt, quarantine, release, storage, dispensing, transfer, shipment, inventory control, and disposal of regulated materials in compliance with procedures and regulatory requirements.
• Coordinate material supply and logistics operations including sampling, testing, inventory management, inter-site transfers, and shipments.
• Administer reference standards and sample management programs with qualification, issuance, reconciliation, storage monitoring, and disposal activities.
• Ensure controlled substance compliance and accountability through inventories, recordkeeping, reporting, destruction activities, and security controls.
• Support regulatory licensing, reporting, inspections, and readiness with DEA registrations and state licenses.
• Develop and maintain compliance systems and procedures for materials and controlled substances.
• Collaborate cross-functionally with Quality, Regulatory Affairs, Supply Chain, Manufacturing, Legal, external suppliers, laboratories, and regulatory agencies.
• Perform additional responsibilities and special projects as assigned.

Skills

Microsoft Office

Regulatory compliance

Documentation skills

Communication skills

Organizational skills

Education

Bachelor’s degree in Science / Chemistry / Supply Chain / related field

Job description

Fresenius Kabi in Melrose Park is seeking a Materials Management & Controlled Substance Specialist to oversee compliant lifecycle management of development materials, including APIs and regulated substances, ensuring DEA and regulatory adherence.

You will manage receiving, storage, dispensing, transfers, and disposal, serve as SNSR, and collaborate with Quality, Regulatory Affairs, Supply Chain, and regulatory agencies to maintain inspection readiness and ongoing compliance.