The DEA Compliance Specialist must be able to perform each essential duty satisfactorily. The qualified individual will play an essential role in providing support in the oversight of the daily activities of the DEA Compliance program as it relates to Title 21 CFR, Part 1300-End and the DEA, as well as ensuring compliance with all federal and state regulations. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ensure compliance and regulatory standard operating procedure (SOP’s) guidelines are being followed.
- Assist with the development and revision of procedures to ensure accurate documentation, traceability, and accountability as it relates to CDS to minimize the risk of diversion.
- Assist with coordination of all movements of controlled dangerous substances (“CDS”) from receiving, order fulfillment, shipping, returns, etc.
- Investigate inventory discrepancies and in-transit losses and report findings to the DEA as necessary.
- Investigate suspicious ordering of CDS based upon established criteria and report findings to the DEA.
- Conduct site visits of member pharmacies to monitor/investigate DEA compliance and suspicious ordering.
- Conduct pharmacy dispensing data analysis of member pharmacies to monitor/investigate DEA compliance and suspicious ordering.
- Preparation and submission of periodic reports for the DEA (ARCOS, YERS, etc.).
- Provide support with DEA audits both internally and externally to ensure that established procedures are being followed and documented, required reports are being filed, and inventories are reconciled.
- Assist with ensuring proper federal and state licensure and registration necessary to receive and ship product.
- Assist with ensuring proper federal and state licensure of all customers and vendors.
- Work with DEA Compliance management and security to ensure facility and CDS storage locations are compliant with state and federal regulations.
- File, scan, and audit all documentation and forms.
- Perform other duties as assigned.
- Bachelor’s Degree in a scientific or business-related field with 3 years of experience in Regulatory or Compliance field. Associates Degree in a scientific or business-related field with 5 years of experience in Regulatory or Compliance field. High School/GED with 7 years of DEA Compliance experience. Related DEA Compliance education, experience, training and/or certifications will be considered and may, in some circumstances, be acceptable in lieu of a degree.
- Pharmacy Technician Certification is desirable.
- Knowledgeable and experienced in DEA regulations, specifically Title 21 CFR 1300-End.
- Ability to take initiate as issues arise.
- Ability to read and interpret documents such as safety rules, operations manual, and written directions.
- Must have a valid Driver license and reliable transportation with current auto insurance.
- Thorough knowledge of pharmaceuticals including the application of DEA Regulations.
- Must be proficient in MS Word and Excel software programs.
- Excellent interpersonal and communication (written and verbal) skills.
- Excellent analytical, troubleshooting, and problem-solving skills.
- Excellent time management skills.