Materials Management & Controlled Substance Specialist 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:
This professional 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. Perform 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.
