Materials Management and Controlled Substance Specialist

Fresenius Kabi USA; Melrose Park (IL); Sur place; USD 70 000 - 75 000; Plein temps

Avantages offerts par ce poste

401(k) plan with company contributions

Paid vacation, holidays and personal/f

Employee assistance program

Health, dental and vision insurance

Résumé du poste

Fresenius Kabi USA is seeking a Materials Management & Controlled Substance Specialist to oversee compliant lifecycle management of development materials, including controlled substances, across receiving, storage, dispensing, and distribution.

The SNSR, under this role, ensures DEA compliance and regulatory readiness, coordinating cross-functionally with Quality, Regulatory, Supply Chain, and Manufacturing to sustain secure and efficient operations.

Qualifications

• 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.
• Strong regulatory and compliance knowledge related to pharmaceutical materials.
• English language proficiency for policies and workplace communications.

Responsabilités

• Oversee receipt, quarantine, release, storage, dispensing, transfer, and disposal of materials per regulations.
• Coordinate material supply and logistics including sampling, testing, inventory, transfers, shipments.
• Administer reference standards and sample management programs.
• Ensure controlled substance compliance and accurate recordkeeping and reporting.
• Support regulatory licensing, inspections readiness, and regulatory submissions.

Connaissances

Controlled substance recordkeeping &  

Regulatory compliance knowledge

Excellent organizational,communication

English proficiency for policies

Formation

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

Certification in DOT and IATA shipping procedures

Outils

Microsoft Office

Description du poste

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.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. 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.

Coordinate 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.

Administer 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.

Ensure 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.

Support 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.

Develop and Maintain 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.

Collaborate 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.

Requirements

Perform additional responsibilities and special projects as assigned.

• 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.