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 Director DEA Compliance in a timely manner. 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 cosignees 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.
Education:
Bachelors Degree (BA/BS) with 2 yrs of experience - Required
Experience:
2 years or more in Regulatory, Compliance, Law Enforcement or Military equivalent.
Skills:
Great Time management - Advanced
Excellent communications, writing and organization skills, with good people skills. - Advanced
Analytical thinker with the ability to analyze information and uncover errors and inaccuracies during inventory reviews or audits. - Advanced
Microsoft Office skills particularly Word and Excel - Intermediate
Specialized Knowledge:
knowledge and experience in FDA and DEA regulations, particularly 21 CFR 1300 to 1321.01Basic software skillsKnowledge and experience in the areas (min 3) of ARCO, NYSDOH, YERS, DEA documents to include registration application, import/export permit application and quota request forms.
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
