DEA Coordinator

in Levittown, PA

Job #:535442

Practice Area: IT

Date Posted: 10/28/2020

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The DEA Associate (Coordinator) is accountable for the site activities related to DEA controlled substances as well as ensuring site compliance with DEA Regulations and Torrent SOPs.  The DEA Associate will report to the Head of QMS and Compliance and efficiently conduct all duties and responsibilities assigned and or delegated by the Head of QMS and Compliance.      

 

Essential Duties and Responsibilities:

  • Manage receipt, storage, dispensing, shipment and record keeping of controlled substances
  • Maintain DEA Registrations for the site including those for R&D and Analytical departments and provide support during DEA audits and inspections.
  • Maintain list of authorized personnel
  • Preparation, maintenance, shipping and ordering of DEA 222 form.
  • Coordinate controlled substance destruction with Reverse Distributor.
  • Manage physical inventory counts (i.e. Biennial, Mid/Year-End).
  • Manage the completion and submission of required DEA records and reports for controlled substances: ARCOS Reports, Year End Reports, Quota Submissions, Import/Export Applications, SOP’s.
  • Conduct periodic internal audits of manufacturing and analytical departments for continuous improvement of the CS process and ensure regulatory compliance with 21 CFR (Part 1300 – End).
  • Assist in conducting Due Diligence within the Order Analysis System, company partners and customers.
  • Maintain documentation to support DEA inspection-readiness (i.e., API/batch reconciliations).
  • Receipt, log-in and inventory control of DEA related API’s, excipients, reference standards and raw materials.
  • Understands timelines and demonstrates a sense of urgency in work and in responding to colleagues.
  • Proactive, good organizational and time management skills

·         Follow and enforce GMP and DEA practices and applicable Standard Operating Procedures. Report any concerns immediately to the management.

·         Assist with training of new and current employee on DEA responsibilities and participate in department or company projects/initiatives as requested.

·         Interact with any and all other departments to resolve any issues regarding DEA materials

·         Other duties may be assigned by the Head of QMS and Compliance, or Site Head of Quality

 

Safety Requirements:

  • Ensure adherence to all personal protective equipment:
  • Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources

 

Competencies/Skills:  

  • Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.
  • Strong organizational skills and the ability to multitask         
  • Demonstrated ability in working independently and as part of a team.
  • Must be able to work in a cross-functional environment interacting with other internal departments and external vendors
  • Excellent communication (oral and written) and interpersonal skills
  • Knowledge of cGMPs and DEA regulations (CFR Part 1300 - End).  Knowledge of liquid processes preferred.
  • Ability to work evenings, weekends, holidays and on-call.

                               

Education and/or Experience:                                                 

  • Bachelor’s degree  
  • Minimum of three (3) years of experience working in a GMP environment.
  • Minimum of three (3) years of experience in a pharmaceutical environment handling DEA materials.

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