layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Materials Management and Controlled Substance Specialist at Fresenius Kabi | LAYIQ

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.

Materials Management and Controlled Substance Specialist

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