Materials & Controlled Substances Compliance Specialist

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

Benefits offered by this job

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Medical, dental and vision coverage

Job summary

Fresenius Kabi USA, LLC is seeking a Materials Management & Controlled Substance Specialist in Melrose Park, IL to oversee compliant lifecycle management of development materials, APIs, and controlled substances. You will ensure DEA and regulatory compliance, manage receiving, storage, dispensing, and distribution, and serve as SNSR for DEA-related activities.

The role requires a Bachelor's degree and 2+ years of experience in regulated materials, with strong documentation and office software

Qualifications

• Bachelor's degree or higher in science, chemistry, supply chain, or related field.
• Excellent organizational and documentation skills.
• Strong understanding of regulatory and compliance requirements for pharmaceutical materials and controlled substances.
• Proficient in Microsoft Office applications.

Responsibilities

• Manage the Materials Management Program, including receipt, quarantine, storage, dispensing, transfer, shipment, inventory control, and disposal of regulated materials in compliance with procedures and regulations.
• Coordinate material supply and logistics, including sampling, testing, inventory management, inter-site transfers, shipments, and customs clearance.
• Administer reference standard and sample management programs, including inventories, retention samples, disposal activities.
• Ensure controlled substance compliance and accountability, including inventories, recordkeeping, reporting, destruction, and security controls.
• Support regulatory licensing, reporting, and inspection readiness, maintaining registrations and coordinating inspections and audits.
• Develop and maintain compliance systems and procedures for materials and controlled substances.
• Collaborate cross-functionally to support business operations across Quality, Regulatory Affairs, Supply Chain, Manufacturing, Legal, and external partners.
• Perform additional responsibilities and special projects as assigned.

Skills

Organizational skills

Documentation skills

Regulatory compliance knowledge

Communication skills

Education

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

Tools

Microsoft Office

Job description

Fresenius Kabi USA, LLC is seeking a Materials Management & Controlled Substance Specialist in Melrose Park, IL to oversee compliant lifecycle management of development materials, APIs, and controlled substances. You will ensure DEA and regulatory compliance, manage receiving, storage, dispensing, and distribution, and serve as SNSR for DEA-related activities.

The role requires a Bachelor's degree and 2+ years of experience in regulated materials, with strong documentation and office software