Materials Management, Controlled Substance Specialist

• Oversee receipt, quarantine, release, storage, dispensing, transfer, shipment, inventory control, and disposal of raw materials, APIs, excipients, reference standards, RLD materials, and other regulated materials
• Support material lifecycle activities including sampling, testing, inventory management, inter-site transfers, domestic and international shipments, hazardous material transportation, customs clearance, and material availability
• Administer reference standard, reserve sample, and retention sample management programs
• Manage controlled substance inventories, dispensing, reconciliation, recordkeeping, reporting, destruction activities, and physical security controls
• Maintain DEA registrations and state licenses, coordinate regulatory submissions, support inspections and audits, and maintain inspection-ready documentation
• Create, review, implement, and improve procedures, records, training, and operational controls
• Partner with Quality, Regulatory Affairs, Supply Chain, Manufacturing, Legal, Corporate Services, suppliers, laboratories, and regulatory agencies
• 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 and reporting experience
• Proficiency in Microsoft Office applications
• Strong organizational, communication, and documentation skills
• Strong understanding of regulatory and compliance requirements related to pharmaceutical materials and controlled substances
• Ability to effectively speak, read, write, and understand English
• Certification in DOT and IATA shipping procedures preferred

Demonstrates expertise in managing the lifecycle of pharmaceutical materials, including compliance with regulatory requirements and controlled substance management. Proficient in inventory control, documentation, and collaboration with cross-functional teams to ensure operational efficiency.

• Controlled Substance Recordkeeping
• Regulatory Compliance
• Inventory Management
• Microsoft Office Proficiency
• DOT and IATA Certification

• Inventory Control
• Material Lifecycle Management
• Sampling and Testing
• Hazardous Material Transportation
• Regulatory Submissions
• Documentation Management
• Operational Controls
• Controlled Substance Management
• Quality Assurance
• Customs Clearance

• Strong Organizational Skills
• Effective Communication
• Attention to Detail

• DOT Certification
• IATA Certification

• Pharmaceutical Materials
• APIs
• Excipients
• Reference Standards
• DEA Registrations
• Inspection-Ready Documentation
• Supply Chain Management
• Regulatory Affairs
• Quality Control
• Controlled Substances