Manager of Controlled Substance Operations
Qualitest Pharmaceuticals - Charlotte, NC

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This position will be responsible for supervision of the daily activities of the Controlled Substance Coordinators at the Charlotte Plant.Responsibilities: Develops and maintains a schedule for the coordinators, based on the week’s production plan that will allow for effective coverage of all controlled substance areas of responsibility. This will require flexibility and contingent planning should the production plan change on short notice.These areas of responsibility include, but are not limited to: All controlled substance movement between all areas, including: manufacturing, packaging, warehouse, QC or research operations.Controlled substance room clearance for accountability purposesSecuring of controlled productsClearance of manufacturing or packaging debris for disposalMaking rounds through areas working with controlled products to assure DEA complianceEscorting contractors, consultants, etc. when in controlled drug storage, manufacturing or testing areas (secondary responsibility)Supervision of all vault and cage operations Develop and implement a rotation plan across the buildings for the coordinators that will allow for varied employee interaction and limit the potential for diversion.Assure personnel chosen for the coordinator role have historically met or exceeded their current job expectations; have been with the company at least six months as a permanent employee and that they conduct themselves with the strictest of moral and ethical standards.Coach, mentor and provide support or direction to the coordinators to assure their success.Conduct performance reviews for the Controlled Substance Coordinator positions on a yearly basis, taking into consideration feedback from Security, DEA Compliance and Operations.Seek to develop good relations with all Controlled Substance Coordinator “customers” while adhering to company and DEA regulations.Keep an open mind and elevate suggestions for improvement or concerns to VP Plant Operations, Director DEA Compliance and Director, Security. Secure approval from these three individuals prior to making any changes to current practice.Work with the Director, DEA Compliance and the Director, Security to assure all coordinators receive proper training in these areas on a routine basis.Attend appropriate seminars and/or participate in peer groups to stay current on DEA regulations and abuse and diversion trends.Requirements: Bachelor’s degree required, Master's degree preferredRequires yearly cGMP, DEA and Safety trainingKnowledge of Qualitest/Endo controlled products, policies & proceduresPrior vault and/or cage accessDiplomatic approach to conflict resolutionLeadership or supervisory experience (either directly or indirectly)Able to exercise authority in a matter that gains respectStrives to make informed decisions and to communicate requirements effectivelyUnderstanding of pharmaceutical manufacturing and/or packaging processesOther: Must have been employed by company as a permanent employee for at least six months (with a preference for 12 months or greater), and have performance reviews at the meets or exceeds expectation level.
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