Overall, the Sr. DEA Specialist will be responsible for ensuring compliance with the reporting requirements of the DEA. This involves generating ARCOS manufacturing reports, UN reports, End of Year 1/31 Letters, quota applications and import/export documents.
• 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 base/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.
- Implementing goals, objectives and practices for efficient and cost effective management of allocated resources
- Communicating clearly and concisely, both orally and in writing
- Complying with company policies, practices and procedures, including safety rules and regulation.
- Establishing and maintaining cooperative working relationships with others
- Handling multiple duties and assignments
- Interfacing with regulatory agencies
- Effectively managing timelines
- Organizing files under regulatory scrutiny
- Current Drug Enforcement Administration (DEA), Good Manufacturing Practices (cGMP), and other applicable regulatory requirements
- Production and production planning processes
- Company’s product line and organizational structure
- English usage, spelling, grammar and punctuation
- Computer program applications such as Outlook, MS Word, MS Excel and PowerPoint
- Basic mathematical computations and applications
- Bachelor’s degree in related field from an accredited college or university
- 6-10 years’ experience preferably within the food, cosmetic or pharmaceutical industry, or equivalent combination of education and experience
Qualitest is an equal opportunity employer .
Endo Pharmaceuticals - 20 months ago
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Endo Health Solutions, formerly known as Endo Pharmaceuticals, wants the pain to end, preferably through the drugs it acquires and markets....