Catalent, Inc

DEA Compliance Specialist

Winchester, KY

Sponsorship not specifiedDetected 11 hours ago

ProcurementPerformance ManagementCustomer SupportClinical TrialsGMPFDA RegulatoryCommunicationProblem SolvingOrganizational Skills

About the role

You will implement and ensure execution of policies and practices for compliance with DEA regulations at the Winchester site.
This position also provides technical support by interpreting and applying federal and local Controlled Substance Act regulations to site processes and procedures.
Monitor and maintain all registration requirements to ensure renewals are received and processed.
Maintain controlled substance and listed chemical files and perform reconciliation on controlled substance products, including shipping, receiving, Form 222, ARCOS, correspondence, destruction, procurement, and supplemental quota.
Provide support to departments involved in shipping and receiving controlled substance samples.
Maintain controlled substance documentation and accountability while remaining alert to diversion and theft risks.
Maintain, review, and verify ARCOS monthly and year-end reports, and perform state ARCOS and Form 106 reporting.
Obtain procurement drug quota and raw material to support production.
Assist EH&S with security surveillance in production areas to support controlled substance handling and regulatory guidelines.
Maintain, review, and verify background checks for controlled substance area access every 5 years.

Winchester has a long commercial manufacturing track record, having launched 100+ products and producing billions of tablets and capsules annually, making it a critical site within Catalent's oral dose network.

The site specializes in complex and controlled‑release oral dose technologies, supporting product development, technology transfer, and commercial manufacturing across pharmaceutical and consumer health programs.

This listing is sourced directly from Catalent, Inc's careers page and normalized into a canonical job model.