Manager of DEA Compliance
Location: Huntsville, Alabama
Description: Qualitest Pharmaceuticals is looking of Manager of DEA Compliance right now, this occupation will be ordered in Alabama. For complete informations about this occupation opportunity kindly read the description below. Under general direction of the Director, DEA Compliance, individual ensures all DEA (Drug Enforcement Administration) reporting requirements are met through the effective superv! ision of the DEA Compliance Group. Responsible for overseeing the day-to-day operations at the Huntsville, AL and Charlotte, NC facilities
Key Responsibilities:
Carries out all responsibilities in accordance with the organization’s policies and procedures, state, federal and local laws.
Responsible for ensuring compliance with the reporting requirements of the DEA. This involves the generation of ARCOS reports, End of Year 1/31 Letters, quota applications, theft/loss reports (106 Forms), destruction reports (41 Forms), and import/export documents. In most cases, the incumbent would be supervising those submitting these reports. However, some reports may also be required to be submitted directly by this individual. Person must be willing to be hands-on when necessary.
Coordinates the end of year inventory process for multiple sites. Analyzes inventory information and other data submitted to the group to complete the End of Year 1/31 le! tters. Submits the report to DEA and works with the agency to ! resolve any issues.
Works closely with manufacturing and packaging, QC/QA, research & development and distribution departments to gather production, sample, shipment, or transfer information and analyzes it for accuracy.
Interfaces with other departments such as marketing, clinical research, purchasing and production in order to determine and monitor quantities of Schedule I and II substances needed by each group. Converts all quantities into DEA format (i.e., anhydrous base/salt, kgs/gms), and prepares or oversees the quota requests for each site for submission to DEA.
Interfaces with DEA as required on issues relating to reporting requirements and other miscellaneous requests.
Manages data reflecting all shipments, receipts and destructions as they occur throughout the year and oversees or generates ARCOS reports for periodic submission to DEA.
Submits theft/loss reports (106 Forms) to DEA. Involves coordinating internal invest! igation efforts, corrective actions and proving follow up requested by DEA.
Facilitates DEA inspections for the Huntsville, AL and Charlotte, NC facilities and assures management is kept apprised as the inspection progresses.
Works with departments handling controlled products to assure Standard Operating Procedures are created that include DEA requirements. Writes or updates DEA Compliance department procedures governing the import or export of controlled substances, ARCOS reporting, End-of-Year reports, quota requests, etc.
Reviews lists of all controlled substances to be destroyed by the Company. Ensures that lists have been properly completed and that they include the date of destruction, exact location, time, method, etc. Submits destruction requests to DEA.
Provides supervision, guidance and training to the Compliance Specialists to allow for cross-functional development and understanding of DEA requirements. Completes performance r! eviews for these individuals, establishing goals & objectives and asses! sing progress to date.
Reviews departmental budget for discrepancies and follows up with Director or other departments should corrections or modifications be necessary.
Assures that the Legal Department is advised of any changes to the business that may affect DEA or State registrations.
Assures that power of attorney documents are generated and maintained as needed.
Assists with new employee training to ensure that individuals have a thorough understanding of DEA requirements.
Acts as a back-up to the Director, Controlled Substance Compliance as a key decision maker for the organization on all controlled substance matters.
Education and Knowledge Requirements:
Bachelor’s degree in a related field from an accredited college or university
Five (5) years’ experience handling DEA activities in a pharmaceutical manufacturing environment or an equivalent of education and experience.
Current Go! od Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and other applicable regulatory requirements
Production planning/materials management processes
Familiarity with Lab and R&D practices and procedures
Solid dosage form and/or liquids manufacturing knowledge
Company’s product line
English usage, spelling, grammar and punctuation
Computer program applications such as Mapics, WMS or other ERP systems. Knowledge of Lotus, MS Word, MS Excel, PowerPoint and Outlook.
Strong mathematical computations and applications
Skills and Abilities Requirements:
DEA Compliance
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 regulations.
Establishing and maintaining cooperativ! e working relationships with others.
Handling multiple duties and assignments
Interfacing with regulatory agencies
Effectively managing timelines
Organizing files under regulatory scrutiny
Working independently
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If you were eligible to this occupation, please send us your resume, with salary requirements and a resume to Qualitest Pharmaceuticals.
Interested on this occupation, just click on the Apply button, you will be redirected to the official website
This occupation starts available on: Thu, 23 May 2013 20:44:44 GMT
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