DEA Compliance Specialist
General Description Of Position
Play an essential role in the day-to-day activities of the DEA Compliance program as it relates to Title 21 CFR, Part 1300-End and the Drug Enforcement Administration (DEA), as well as ensure compliance with all federal and state regulations. Coordination and support of all DEA and the SC-DHEC regulated activities for all PAI Greenville operations. Perform as backup to the Associate Director of DEA Compliance.
Essential Duties And Responsibilities
• This position is considered full time (40 hours a week on average, sometimes more) position. Follows all Policies, SOP’s, cGMPS, Work Instructions, and Management instructions.
• Perform and support day-to-day operations to maintain DEA Federal and SC-SHEC State compliance, and help identify and achieve departmental strategies and objectives.
• Secondary liaison for the DEA and SC-DHEC inspections.
• Creation and revision of procedures to ensure correct documentation, traceability, and accountability as it relates to DEA controlled substances and SC-DHEC activities to minimize the risk of diversion..
• Preparation and submission of periodic reports to the DEA (ARCOS, CSOS, YERS, etc.), procurement quota requests.
• Coordinate and perform reconciliation audits of controlled substance inventories for all DEA Registrations. (Annual, Biennial, Year-end, etc.).
• Participate in controlled substance inventory discrepancies, in-transit losses, and suspicious orders, and report findings to the DEA, SC-DHEC-Bureau of Drug Control and state BOP, as necessary.
• Ensure all facilities and controlled substance storage locations are compliant with DEA and SC-DHEC regulations.
• Work with DEA Compliance and Quality management and Security to ensure all facilities and controlled substance storage area are compliant with DEA and SC-DHEC regulations.
• Coordination of Controlled substance destruction process both internal and external. .
• Maintain an understanding of and abide by all cGMPs, compliance, regulatory and quality requirements.
• Filing and auditing of all DEA Compliance documentation.
• Backup to the Associate Director of DEA Compliance.
• Perform any other related duties as required or assigned.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty mentioned satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education And Experience
Knowledge of a specialized field (however acquired). High school diploma plus 2-5 years related experience and/or training. College/University degree is preferred. Or an equivalent combination of education and experience will be considered.
PAI Pharma is a nicotine-free campus , meaning the use of nicotine products—including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances—is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine . By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees.
Pharmaceutical Manufacturing
Finance and Sales
Full-time