About the Role
The DEA Compliance Analyst will be responsible for ensuring an organisation complies with regulations set by the Drug Enforcement Administration regarding controlled substances, recordkeeping, security, reporting, and licensing.
Key Activities
Knowledgeable on all matters of DEA compliance related to research, manufacturing, and distribution of controlled substances, including licensing, procurement, movement of materials, production, shipment, and destruction.
Facilitate external audits and site inspections; serve as primary point of contact for federal and state regulatory agencies.
Respond to forms, warning letters, or administrative actions issued by regulatory agencies.
Oversee and renew DEA registrations, inventory records, and security documentation.
Maintain applicable state and federal licenses.
Track regulatory changes affecting controlled substances and labelling requirements.
Lead and participate in internal quality system audits to ensure DEA compliance.
Coordinate with Quality Assurance and Regulatory teams on SOP compliance, change controls, and deviation reports.
Maintain accurate compliance documentation and ensure timely reporting.
Collaborate with legal counsel to ensure adherence to all applicable laws and regulations.
Additional duties may be assigned as business needs evolve.
Maintain compliance with all DEA and state registrations.
Support schedule-specific controlled substance requirements.
Submit Schedule I and II quota applications when applicable.
Maintain organised regulatory files and documentation.
Request controlled substance confirmations from the DEA.
Prepare and track chemical preparation exemption applications.
Liaise with DEA, Procurement, and Shipping on import/export activities.
Interpret DEA requirements and identify gaps between regulations and company practices.
Review controlled substance orders to ensure regulatory and internal compliance.
Maintain accurate and complete records for receipts, invoices, and shipping documents.
Hold Power of Attorney for completion and tracking of DEA 222 Forms.
Review and release orders through Suspicious Order Monitoring systems.
Maintain customer and compliance records.
Conduct biennial inventories of controlled substances.
Perform cycle counts and maintain inventory accuracy.
Prepare and submit ARCOS quarterly reports.
Support reporting related to diversion, theft/loss, or inventory discrepancies.
Support audits, inspections, and regulatory reviews.
Coordinate and document internal DEA compliance audits.
Develop and deliver training on controlled substance policies and procedures.
Maintain compliance documentation, training records, and personnel files.
Track employee training completion and policy acknowledgements.
Coordinate background screening processes as required.
Preferred Skills
Familiarity with manufacturing and production environments.
Proficiency with Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat.
Strong attention to detail, organisational skills, and ability to manage multiple priorities independently.
Education and Experience
Bachelor’s degree in Biology or a related field.
2+ years of related industry experience.
3–5 years of DEA compliance experience, including ARCOS reporting and DEA 222 Forms.
Strong knowledge of DEA and FDA regulations, the Controlled Substances Act (CSA), and the Chemical Diversion and Trafficking Act (CDTA).
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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