DEA Compliance Analyst

Job Summary The DEA Compliance Analyst is responsible for ensuring full regulatory compliance regarding the research, manufacturing, and distribution of controlled substances. This role requires a deep understanding of DEA and FDA regulations, including licensing, procurement, movement of material, production, and destruction. The analyst serves as a primary point of contact for federal and state regulatory agencies and facilitates both internal and external audits. 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. Coordinate and report on the destruction of controlled substances with reverse distributors and internal Quality teams. 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. Desired Skills and Experience DEA compliance, FDA regulations, controlled substances, Controlled Substances Act, Chemical Diversion and Trafficking Act, 21 CFR, DEA registrations, California state registrations, Schedule I-V licensing, Schedule I and II quotas, ARCOS reporting, DEA 222 Forms, Suspicious Order Monitoring System, Know Your Customer, controlled substance procurement, controlled substance movement, controlled substance manufacturing, controlled substance distribution, controlled substance destruction, import/export compliance, regulatory compliance, regulatory audits, site inspections, internal audits, quality management systems, SOP compliance, deviation reports, compliance documentation, licensing, regulatory reporting, inventory management, biennial inventories, cycle counts, diversion reporting, theft and loss reporting, security systems, reverse distribution, policy development, staff training, background checks, MS Office, Excel, PowerPoint, Adobe Acrobat #J-18808-Ljbffr Bayside Solutions