• Associate DEA Compliance Auditor

    Amneal Pharmaceuticals (Branchburg, NJ)


    Description:

    The DEA Compliance Auditor will maintain all compliance regulations and laws that are required by the U.S. Drug Enforcement Administration as specified by (21 CFR 1300 to 1321.01) for Amneal's assigned facilities.

    Essential Functions:

    + Execute DEA documents which include, but are not limited to: Registration applications, renewals, and updates. Drug code additions. Import and export permit application forms. DEA 222 order forms for procurement of API, USP standards, RLDs, etc.

    + Ensure that periodic inventories and reports required by the Drug Enforcement Administration and various state reports are accurate and submitted to the Director DEA Compliance promptly. These reports include "ARCOS", Biennial inventory, and Year End Reports.

    + Ensure effective control measures and Compliance SOP guidelines are being followed at all facilities.

    + Coordinate destruction of scheduled materials, waste, or by products.

    + Conduct periodic audits and manage Amneal controlled substance record keeping, inventory, and security systems to prevent diversion of controlled substance raw materials and finished products.

    + Oversee suspicious order monitoring process.

    + Oversee the handling of Loss/Theft filling reports with local DEA office when needed.

    Additional Responsibilities:

    + Coordinate investigations of suspicious controlled substance orders from consignees with Amneal NY DEA Compliance section.Coordinate priorities with elements of Amneal's logistics/shipping team to ensure that controlled substance products are transported in the manner prescribed by DEA regulations to prevent diversion. Assume other duties as assigned.