Sr. DEA Compliance Specialist
Location: Huntsville, Alabama
Description: Qualitest Pharmaceuticals is at present looking to employ Sr. DEA Compliance Specialist right now, this position will be assigned in Alabama. Detailed specification about this position opportunity please give attention to these descriptions. Overall, the Sr. DEA Specialist will be responsible for ensuring compliance with the reporting requirements of the DEA. This involves generating AR! COS manufacturing reports, UN reports, End of Year 1/31 Letters, quota applications and import/export documents.Key Responsibilities: Works closely with manufacturing departments to gather production and transfer information, and analyzes it for accuracy.Assists with oversight of controlled substance inventories for manufacturing, import and export registrations. Analyzes inventory information and other data submitted to the group on a monthly basis to prepare the End of Year 1/31 report and UN reports.Manages data reflecting all transfers, receipts, samples and destructions as they occur throughout the year and generates timely ARCOS manufacturing reports for periodic submission to DEA.Interfaces with other departments such as Sales & Marketing, R&D, Clinical Research, Purchasing, Materials Management and Manufacturing in order to determine and monitor quantities of Schedule I and II substances required.
Converts all quantities into DEA format (i.e., anhydrous bas! e/salt, kgs/gms), and prepares the quota requests for each DEA! Manufacturer or Importer Registration, for submission to DEA.Submits manufacturing theft/loss reports (106 Forms) to DEA as needed. Involves partnering with management, Security and Customer Service on investigation efforts and corrective actions, and providing any follow up requested by DEA.Reviews lists of all controlled substances to be destroyed by the Company under the manufacturing registrations. Ensures that lists have been properly completed and that they include the full product description, controlled substance content, date of destruction, exact location, time, method, etc. Submits destruction requests to DEA for all registrations, with the exception of the Distributor registration.Completes DEA 222 order forms for signature by an authorized power of attorney, for the Manufacturer and Importer DEA registrations.
Records form information in the appropriate logbook for tracking purposes. Assures amount ordered does not exceed quota granted.Interfaces with! DEA as required on issues relating to the reporting requirements and to other miscellaneous requests.Provides guidance and training to the DEA Compliance Specialist to allow for cross-functional development and greater understanding of DEA requirements.Carries out responsibilities in accordance with the organization’s policies and procedures, state, federal and local laws, including safety and cGMP regulations.Skill Requirements: Implementing goals, objectives and practices for efficient and cost effective management of allocated resourcesCommunicating clearly and concisely, both orally and in writingComplying with company policies, practices and procedures, including safety rules and regulation.Establishing and maintaining cooperative working relationships with othersHandling multiple duties and assignmentsInterfacing with regulatory agenciesEffectively managing timelinesOrganizing files under regulatory scrutinyWorking independentlyKnowledge Requirements: Current Drug ! Enforcement Administration (DEA), Good Manufacturing Practices (cGMP), ! and other applicable regulatory requirementsProduction and production planning processesCompany’s product line and organizational structureEnglish usage, spelling, grammar and punctuationComputer program applications such as Outlook, MS Word, MS Excel and PowerPointBasic mathematical computations and applicationsEducation Requirements: Bachelor’s degree in related field from an accredited college or university6-10 years’ experience preferably within the food, cosmetic or pharmaceutical industry, or equivalent combination of education and experience
- .
If you were eligible to this position, please send us your resume, with salary requirements and a resume to Qualitest Pharmaceuticals.
Interested on this position, just click on the Apply button, you will be redirected to the official website
This position will be started on: Sat, 27 Apr 2013 10:28:44 GMT
Apply Sr. DEA Compliance Specialist Here