DEA Compliance Specialist
Location: Huntsville, Alabama
Description: Endo Pharmaceuticals is hiring DEA Compliance Specialist right now, this occupation will be reside in Alabama. Detailed specification about this occupation opportunity please give attention to these descriptions. will be responsible for ensuring compliance with all DEA (Drug Enforcement Administration) reporting requirements. This involves generating reports and preparing documents for subm! ission to DEA.
Key Accountabilities:
Responsible for ensuring compliance with the distribution reporting requirements of the DEA. This involves generating ARCOS reports for Distribution, inventory data to support the end of year or 1/31 letters or UN reporting, generating 106 forms for in-transit thefts/losses and participating in the review and/or reporting of suspicious orders.
Reviews state required distribution reports for accuracy and submits them to the appropriate State agency. Works with Distribution and IT to resolve any discrepancies.
Assists with responding to subpoenas or other law enforcement inquiries for product or distribution reports. Informs management, Legal and Security of the request and the outcome.
Analyzes and spot checks Distribution cycle counts, end of year inventory and other accompanying data submitted to the DEA Compliance Group, to support the end of year report filing (1/31 letter).
Work! s closely with Distribution to gather data reflecting all ship! ments, receipts and destructions. Analyzes the data for accuracy throughout the year and uses this information to generate ARCOS reports for periodic submission to DEA.
Interfaces with other departments such as Distribution, Customer Service, Sales, Security, Legal or IT to keep abreast of product, facility or process changes affecting the DEA compliance of our distribution facilities.
Completes DEA 106 theft/loss forms for in-transit theft/loss reporting to DEA. Partners with Security, Distribution and management as required to assist with investigative efforts and helps to monitor that any required corrective actions are implemented.
Reviews lists of all controlled substances to be destroyed by Distribution. Assures that these 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 the Distr! ibutor registration and maintains a runny tally of controlled destructions.
Completes DEA 222 order forms for signature by an authorized power of attorney, for the Distributor and Analytical DEA registrations. Records form information in the appropriate logbook for tracking purposes.
Assists customers or suppliers with requests for copies of DEA or State registrations.
Interfaces with DEA as required on issues relating to reporting requirements and other miscellaneous requests.
Carries out responsibilities in accordance with the organization’s policies and procedures, state, federal and local laws, including safety and cGMP regulations.
Education and Experience:
Bachelor’s degree in related field from an accredited college or university, three (3) to five (5) years’ experience preferably within the food, cosmetic or pharmaceutical industries, or an equivalent combination of education and experience.
K! nowledge in the Following Areas:
Drug Enforcement Administratio! n (DEA) regulations, Current Good Manufacturing Practices (FDA) and Distribution processes
Company product line and organizational structure
English usage, spelling, grammar and punctuation
Computer program applications such as Mapics, Outlook, MS Word, MS Excel and/or PowerPoint
Basic mathematical computations and applications
Skills and Abilities:
Adhering to goals, objectives and practices
Communicating clearly and concisely, both orally and in writing
Establishing and maintaining cooperative working relationships with both internal and external customers
Handling multiple duties and assignments
Organizing files under regulatory scrutiny
Effectively managing timelines
Ability to work independently
Interfacing with regulatory agencies
Physical Requirements:
Incumbents in this class are subject to extended periods of sitting, standing a! nd walking, vision to monitor, moderate noise levels.
Qualitest is an equal opportunity employer.
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If you were eligible to this occupation, please email 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 starts available on: Tue, 23 Apr 2013 23:00:22 GMT
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