DEA Compliance Specialist

About Site Catalent's Winchester, KY site is the company's flagship U.S. manufacturing location for large-scale oral solid dose forms, operating from a 180,000-square-foot facility with fully integrated development and analytical services. The site specializes in complex and controlled-release oral dose technologies, supporting product development, technology transfer, and commercial manufacturing across pharmaceutical and consumer health programs. Winchester has a long commercial manufacturing track record, having launched 100+ products and producing billions of tablets and capsules annually, making it a critical site within Catalent's oral dose network. About Site Catalent's Winchester, KY site is the company's flagship U.S. manufacturing location for large-scale oral solid dose forms, operating from a 180,000-square-foot facility with fully integrated development and analytical services. The site specializes in complex and controlled-release oral dose technologies, supporting product development, technology transfer, and commercial manufacturing across pharmaceutical and consumer health programs. Winchester has a long commercial manufacturing track record, having launched 100+ products and producing billions of tablets and capsules annually, making it a critical site within Catalent's oral dose network. Position Summary We have an opportunity for a DEA Compliance Specialist to join our team. In this role, you will provide independent oversight and guidance for manufacturing, warehouse, QC and QA laboratory processes to ensure compliance with DEA and FDA requirements for handling and reconciling controlled substances. You will implement and ensure execution of policies and practices for compliance with DEA regulations at the Winchester site. This position also provides technical support by interpreting and applying federal and local Controlled Substance Act regulations to site processes and procedures. Shift: Monday-Friday 8 AM -5 PM Location: Winchester, KY 100% Onsite The Role Support customer audits of the facility and systems for controlled substances. Monitor and maintain all registration requirements to ensure renewals are received and processed. Maintain controlled substance and listed chemical files and perform reconciliation on controlled substance products, including shipping, receiving, Form 222, ARCOS, correspondence, destruction, procurement, and supplemental quota. Oversee inventory accountability and reconciliation for controlled substances, coordinating inventory according to internal SOPs and CFR requirements. Serve as a resource for interpretation of 21 CFR Part 1300 and beyond. Review and assist in investigations of deviations related to controlled substance accountability and reconciliation issues. Provide support to departments involved in shipping and receiving controlled substance samples. Support new controlled substance products and customers from development to commercial manufacturing. Prepare DEA correspondence and informational packages. Provide training to peers and new employees on DEA compliance and standard operating procedures. Maintain controlled substance documentation and accountability while remaining alert to diversion and theft risks. Review, inspect, and audit processes and documentation for accuracy and compliance at critical points, including critical calculations related to controlled substance accountability. Maintain, review, and verify ARCOS monthly and year-end reports, and perform state ARCOS and Form 106 reporting. Obtain procurement drug quota and raw material to support production. Obtain approval, expedite, and monitor import/export activities. Advise departments on site‑specific controlled substance issues. Assist EH&S with security surveillance in production areas to support controlled substance handling and regulatory guidelines. Maintain, review, and verify background checks for controlled substance area access every 5 years. Maintain DEA Power of Attorney book, DEA GO BOOK, and relevant access logs. Provide oversight in the manufacture, distribution, and testing of controlled substance products. Assist with maintaining site regulatory documents. Manage client relationships. Ensure compliance with cGMPs and Catalent SOPs throughout the facility. Rotate "on call" status with the DEA Compliance Group to cover 24/7 manufacturing operations. Perform other duties as required to support Catalent Pharma Solutions' high performance. The Candidate Minimum Requirements Bachelor's degree; or Associate degree with 1 year of related work experience; or High School Diploma/GED with 2 years of related work experience. Experience in a manufacturing facility. Expertise in 21 CFR Part 1300 and beyond. Excellent verbal and written communication skills. Proficient in English and able to write professionally for business periodicals, technical procedures, or governmental regulations. Strong attention to detail, organizational skills, and ability to multi-task. Demonstrated knowledge as a subject matter expert and resource. Ability to independently prioritize workloads, with strong problem-solving and analytical skills. Team-oriented and able to work well in a cross-functional environment. Knowledge of cGMP regulations and guidance for the pharmaceutical industry. Proficient in Microsoft Windows, Word, and Excel. Ability to work effectively under pressure to meet deadlines. Ability to perform basic algebra and calculate figures such as rates, ratios, percentages, and fractions. Individual may be required to sit, stand, and walk for extended periods. Specific vision requirements include reading written documents and frequent use of a computer monitor. Why You Should Join Catalent Positive and fast-paced working environment focused on continuous improvement and innovation. Competitive Paid Time Off plus 8 paid holidays. Medical, dental, and vision benefits effective on day one of employment. Tuition reimbursement to help you finish your degree or earn a new one. Engaging site-based activities such as NCAA Basketball Brackets, Golf Scrambles, and annual onsite pet adoption events. Employee Resource Groups promoting diversity and inclusion. Green initiatives and community engagement, including Adopt-a-Highway clean-up. Defined career path with annual performance reviews and growth opportunities. WellHub program to support physical and mental wellness. Exclusive discounts through Perkspot from over 900 merchants. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to View email address on click.appcast.io. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. California Job Seekers can find our California Job Applicant Notice HERE. #J-18808-Ljbffr