DEA & Security Specialist

Other Carmel, New York


Description

This position is responsible for implementing policies and procedures to ensure compliance with DEA and security requirements for the Carmel, NY Site. This includes but is not limited to inventory, production compliance, record keeping, company assets and coordination with DEA investigative agents.  This position assists the Associate Director of DEA and Security in every aspect of the regulatory and daily processes at Lannett Company Inc. 

 Key Accountabilities

DEA      

  • Performs as the company’s backup support liasonliaison to the DEA
  • Executables include but are not limited to DEA Form 41, Form 106, ARCOS, CSOS, YERS and Quota
  • Assist Director of DEA and Security with the DEA as required on issues relating to reporting requirements or other miscellaneous requests.
  • Submits reports to the DEA and works with the agency to resolve questions and concerns.
  • Perform other duties as assigned
  • Manage controlled substance handling to ensure DEA regulation compliance.
  • Supervise and authorize entry into DEA controlled areas.
  • Ensure proper security controls are in place for shipping and receiving controlled drugs.

In-House

  • Tracking in-house material transfers through the use of forms and SAP.
  • Compiling data for all controlled substance shipments to ensure accuracy in inventory. This accounts for acquisitions, dispositions and destructions.

 Security

  • Assist in maintaining security measures at LCI Carmel location.
  • Assist in implementing and monitoring of the overall performance of the comprehensive security program

 Required            

  • High School Diploma / GED

 Experience

  • Associates degree preferred or High School Diploma with relevant work experience.
  • 4 – 7 years in a pharmaceutical environment
  • Knowledge of DEA requirements 21 CFR Part 1300

 Specific Skills    

  • Demonstrated ability to prioritize, manage and schedule in a high volume environment to meet project and department objectives while maintaining quality goals.
  • Strong observational skills and attention to detail is required.
  • Must have proficient computer skills. Excel and SAP experience preferred.
  • Must have excellent interpersonal skills, be highly motivated, well organized and be able to develop alternative solutions to complex issues.
  • Experience in facilitating and executing compliance training events
  • Audit experience preferred.
  • Actively promotes and personally observes safety and security procedures, and uses equipment and material properly.

Physical Requirements

  • Must be able to lift 25 pounds.

Scope of Decision-Making

  • Decisions require basic/routine analytical judgment. Plan and perform diversified duties requiring knowledge of a particular field and the use of a wide range of procedures.  Involves the exercise of judgment in the analysis of facts or conditions regarding individual problems or transactions to determine what action should be taken within the guidelines or standard practice.

Level of Supervision Provided:

  • Project direction of other employees performing the same or directly related work, including assigning, reviewing, checking work, eliminating ordinary supervisory/management positions.

 Internal/External Contacts:

  • Regular inside and outside the organization: Requires regular contact with subordinates and/or other departments, with occasional contacts with individuals outside the organization.  Also includes jobs with regular customer/client contacts.