Sr. DEA Compliance Specialist occupation at Endo Pharmaceuticals in Huntsville

Endo Pharmaceuticals is at present looking to employ Sr. DEA Compliance Specialist on Thu, 28 Mar 2013 22:09:42 GMT. 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. Key Responsibilities: • Works closely with manufacturing departments to gather production and transfer information, and analyzes it for...

Sr. DEA Compliance Specialist

Location: Huntsville, Alabama

Description: Endo Pharmaceuticals is at present looking to employ Sr. DEA Compliance Specialist right now, this occupation will be settled in Alabama. More complete informations about this occupation opportunity kindly see the descriptions. Overall, the Sr. DEA Specialist will be responsible for ensuring compliance with the reporting requirements of the DEA. This involves generating ARCOS manufactur! ing 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 base/salt, kgs/gms), and pre! pares 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 am! ount 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 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

Inter! facing with regulatory agencies

Effectively managing timelines!

Organizing files under regulatory scrutiny

Working independently

Knowledge Requirements:
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

Education Requirements:
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

• LI-SR

Qualitest is an equal opportunity employer .
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If you were eligible to this occupati! on, please deliver us your resume, with salary requirements and a resume to Endo Pharmaceuticals.

Interested on this occupation, just click on the Apply button, you will be redirected to the official website

This occupation will be opened on: Thu, 28 Mar 2013 22:09:42 GMT

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