DEA Compliance Associate Auditor

Job Summary

The DEA Compliance Associate Auditor will write, prepare and review documents which they need to maintain compliance in various Amneal facilities.

Essential Functions

• Conduct periodic inventories and reports required by the Drug Enforcement Administration and various state report.s Submit the final reports to DEA Compliance Auditor in a timely manner. Compiles all daily submissions for controlled substance orders and verifies against the DEA 222 form and submits all Controlled Substance orders to DEA regulatory systems within the required 48 hours.
• Administrating in writing DEA documents which include, but are not limited to: Registration applications, renewals and updates. Drug code additions. Import and export permit application forms. Helps complete and/or distribute DEA 222 order forms for procurement of API, USP standards, RLDs, etc.
• Reviewing reports to ensure effective control measures and Compliance SOP guidelines are being followed at all facilities. Communicate all discrepancies to DEA Compliance Auditor.
• Conduct monthly audits of all controlled substance, maintain record keeping, inventory, and security systems to prevent diversion of controlled substance raw materials and finished products. With assistance from compliance auditor, oversee suspicious order monitoring process.
• Manage the destruction process by reviewing and compiling the documentation for destruction in adherence to the destruction schedule. of scheduled materials, waste or by products.

Education

• Bachelors Degree (BA/BS) - Required

Work Experience

• 1 year or more in Regulatory, compliance, law enforcement or military - Required

Skills and Abilities

• Great Time management - Intermediate
• Excellent communications, writing and organization skills, with good people skills. - Intermediate
• Analytical thinker with the ability to analyze information and uncover errors and inaccuracies during inventory reviews or audits. - Intermediate
• Microsoft Office skills particularly Word and Excel - Intermediate

Specialized Knowledge

• Preferred-knowledge and experience in FDA and DEA regulations, particularly 21 CFR 1300 to 1321.01 Basic software skills knowledge 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.