Materials Management and Controlled Substance Specialist

301044 Fresenius Kabi USA, LLC; Leyden Township (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–

Employee assistance program

Health benefits (medical, prescription

Dental and vision coverage

Job summary

Fresenius Kabi USA is seeking a Materials Management & Controlled Substance Specialist to oversee compliant lifecycle management and movement of development materials, including controlled substances. You will ensure DEA compliance, manage receiving, storage, dispensing, and distribution, and serve as the SNSR for inspections.

Salary range is $70,000 - $75,000 with final pay determinations based on experience, education, knowledge, skills, and abilities.

Qualifications

• Bachelor’s degree in Science, Chemistry, Supply Chain, or related field.
• 2+ years of experience in controlled substance recordkeeping & reporting.
• Proficiency in Microsoft Office applications.
• Strong organizational and documentation skills.
• Certification in DOT and IATA shipping procedures preferred.
• English language proficiency is required for all communications.

Responsibilities

• Oversee receipt, quarantine, release, storage, dispensing, and disposal of regulated materials.
• Coordinate material lifecycle activities including sampling, testing, and inventory control.
• Ensure DEA compliance, licensing, and inspections readiness.
• Collaborate with Quality, Regulatory Affairs, Supply Chain, Manufacturing, and Legal.
• Maintain reference standards and sample management programs.

Skills

Regulatory compliance

Recordkeeping & reporting

Documentation

English proficiency

Communication

Organizational skills

Education

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

Tools

Microsoft Office

DOT/IATA shipping procedures

Job description

Job Summary

The Materials Management & Controlled Substance Specialist oversees the compliant lifecycle management and movement of development materials, including controlled substances. This role ensures adherence to DEA and regulatory requirements while managing receiving, storage, dispensing, and distribution activities. The Specialist partners cross-functionally to support secure, efficient, and compliant handling of APIs, controlled substances, and related materials. This role serves as the Site Narcotic Substance Responsible person (SNSR), ensuring full compliance with Drug Enforcement Administration (DEA) regulations related to controlled substances handling, documentation, storage, and inspections.

Salary Range: $70,000 - $75,000 Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

Responsibilities

Manages the Materials Management Program by overseeing the receipt, quarantine, release, storage, dispensing, transfer, shipment, inventory control, and disposal of raw materials, APIs, excipients, reference standards, RLD materials, and other regulated materials in compliance with company procedures and regulatory requirements. Coordinates Material Supply and Logistics Operations by supporting material lifecycle activities, including sampling, testing, inventory management, inter-site transfers, domestic and international shipments, hazardous material transportation, customs clearance, and material availability for development and manufacturing activities. Administers Reference Standard and Sample Management Programs by maintaining inventories of regulatory and non-regulatory reference standards, reserve samples, and retention samples, including qualification, issuance, reconciliation, storage monitoring, periodic inventories, and disposal activities. Ensures Controlled Substance Compliance and Accountability by managing controlled substance inventories, dispensing, reconciliation, recordkeeping, reporting, destruction activities, and physical security controls in accordance with DEA, state, and company requirements. Supports Regulatory Licensing, Reporting, and Inspection Readiness by maintaining DEA registrations and state licenses, coordinating required regulatory submissions, supporting inspections and audits, maintaining inspection-ready documentation, and ensuring ongoing compliance with applicable regulations. Develops and Maintains Compliance Systems and Procedures by creating, reviewing, implementing, and continuously improving procedures, records, training, and operational controls that support materials management, controlled substance management, and regulatory compliance programs. Collaborates Cross-Functionally to Support Business Operations by partnering with Quality, Regulatory Affairs, Supply Chain, Manufacturing, Legal, Corporate Services, external suppliers, laboratories, and regulatory agencies to ensure compliant and efficient management of materials and controlled substances. Performs additional responsibilities and special projects as assigned.

Requirements

Bachelor’s degree in Science, Chemistry, Supply Chain, or related field 2+ years of experience Controlled substance recordkeeping & reporting experience Proficiency in Microsoft Office applications Excellent organizational, communication, and documentation skills Strong understanding of regulatory and compliance requirements related to pharmaceutical materials and controlled substances Certification in DOT and IATA shipping procedures preferred The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status. Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany. Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr