Controlled Substance Specialist II

Controlled Substance Specialist II

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.  The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City, MO is hiring Controlled Substance Specialist II. The Controlled Substance Specialist II will support the state of DEA regulatory compliance of controlled substances at the KCM site through the following: oversee the inventory and other aspects regarding the use and storage of controlled substances in pharmaceutical dosage forms in development, laboratory, manufacturing, and packaging environments. Support all necessary regulations with DEA 21 CFR 1300 to end, Bureau of Narcotics and Dangerous Drugs and state licensure, state reporting and maintaining NABP Drug Distributor Accreditation.

This is a full-time, salary, onsite position. This is a 1st shift position.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role  

• Provide support of controlled Substance to ensure order, receipt and process distributions are observed and recorded per site procedures to assure the inventory records of Controlled Substances are accurate and completed to meet DEA regulations.
• Support training of Authorized Associates approved to work with Controlled Substances and oversight of daily activities.
• Assure new hires are appropriately screened and existing DEA Authorized Associates are rescreened, as required by site procedures while maintaining an accurate list of Authorized Associates at all times.
• Support Audit Ready 365 initiatives including management of DEA inspections through ownership of DEA binder, tracking of observation findings and action completions in Trackwise, and other duties as required.
• Provide support as DEA Subject Matter Expert, as required.
• Support controlled substance programs at KCM to include holding Power of Attorney for DEA Registrations. Complete accurately, file, and submit (as required) DEA 222 forms, DEA imports and exports, completion of DEA renewal applications, File DEA 106s (theft and loss form), ARCOS, YERS, and required end of year reports.
• Provide support of state licensure, including Drug Distributor Accreditation, through the review of applications. Ensure license expiration dates are monitored and renewal applications completed on time to assure KCM operates a GMP facility in compliance with Applicable Laws, including the requirements for state reporting of controlled substances.
• Participate in all inventory variances, deviations, and/or investigations involving controlled substances.
• Perform all other duties and special projects as assigned.
• Meets deadlines according to agreed timeframes and communicate adjustments as needed.
• Conduct all activities in a safe and professional manner consistent with corporate and department policies, procedures, SOPs, GxP and cGMPs.
• Clear understanding of related SOPs, cGMP and regulations as necessary to accomplish daily tasks.
• Adheres to company policies.

The Candidate 

• Bachelor's degree and 1+ years of related experience in dealing with the DEA and associated regulations or experience in the pharmaceutics industry
• High school and 3+ years of related experience in dealing with the DEA and associated regulations or experience in the pharmaceutics industry.Physical
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