DEA Compliance Analyst

Duties and Responsibilities

• Represent the company as the point of contact for federal and state agencies, facilitating site inspections and responding to administrative actions or warning letters.
• Oversee and renew DEA registrations, maintain state and federal licenses, and track regulatory changes affecting labeling and controlled substances.
• Lead internal quality management system audits and coordinate with Quality Assurance and Regulatory departments on SOP compliance and deviation reports.
• Partner with legal counsel to ensure all operations align with applicable laws and regulations.
• Document and file compliance records to ensure timely and accurate reporting.
• Maintain all DEA and California State registrations and address organizational business needs regarding schedule-specific requirements.
• Submit Schedule I and II quota applications and request controlled substance confirmations from the DEA.
• Prepare and track chemical preparation exemption applications.
• Liaise with Procurement and Shipping for import/export activities and complete all necessary paperwork.
• Review internal orders of controlled substances for regulatory compliance.
• Hold Power of Attorney to sign, complete, and track all DEA 222 Forms.
• Review customer orders via the Suspicious Order Monitoring System (SOMS) and maintain Know Your Customer (KYC) data.
• Conduct biennial inventories (twice per year) and perform regular cycle counts to maintain accuracy.
• Prepare and submit quarterly Automation of Reports and Consolidated Orders System (ARCOS) reports.
• Assist in documentation for reporting diversion, theft, loss, or inventory discrepancies.
• Collaborate with Facilities to maintain and upgrade security systems for controlled substance storage.
• Coincide with reverse distributors and internal Quality teams for the destruction of controlled substances.
• Develop policies and train staff on the handling, storage, and shipping of controlled substances.
• Work with HR to administer annual screenings and background checks for applicable positions.

Requirements and Qualifications

• B.S. in Biology or a related field.
• 2+ years of relevant work experience in a related industry.
• 3–5 years of specific DEA compliance and training experience, including ARCOS and 222 Forms.
• Strong knowledge of 21 CFR regulations, the Controlled Substances Act (CSA), and the Chemical Diversion and Trafficking Act (CDTA).
• Experience with DEA Manufacturing and Research Schedule I–V licensing.
• Familiarity with manufacturing and production processes.
• Proficiency in MS Office Suite (Word, Excel, PowerPoint) and Adobe Acrobat Professional.
• Excellent writing, verbal communication, and analytical skills; detail-oriented with a strong ability to prioritize and execute tasks with minimal supervision.