Specialist, DEA Compliance

2 weeks ago

Spring Valley, United States Strides Pharma Inc Full time
Job DescriptionJob Description

The DEA Compliance Specialist, under general supervision, is knowledgeable on all matters of the DEA as it pertains to pharmaceutical testing, manufacturing and distribution of controlled substances. Those matters include licenses, procurement, and movement of material, production, shipment and destruction. Incumbent should also have the ability to interface with governmental agencies and represent the company as needed. Responsible for DEA compliance matters for the Generics Business

DEA Responsibilities

  • DEA coordinator for CII –CV controlled substances: manages/coordinates all DEA-related actives at site
  • Reviews and releases daily orders through Suspicious Order Monitoring System (SOMs) and assures compliance with Suspicious Orders Reporting (SORS)
  • Maintains Know your Customer (KYC) information
  • Conducts year‐end and biennial inventory and report ARCOS quarterly reporting & cycle count inventory via DEA website
  • Coordinates all movement of controlled substances from manufacturing through analytical testing
  • Liaises with Procurement and DEA regarding import/export of controlled substance and completes necessary paperwork
  • Maintains compliance of all DEA, State, and Board of Pharmacy registrations
  • Coordinates all controlled substance destruction with QC, Environmental, Health & Safety and Logistic departments
  • Works with Security department to maintain facility upgrades to security systems
  • Power of Attorney to sign DEA 222 form, responsible for completing, maintaining and tracking all DEA 222 forms
  • Responsible for submitting CII quota applications to DEA; maintain organized DEA files on related activities
  • Coordinates and documents DEA audits for sites and issues audit reports to management upon completion
  • Remains current on DEA regs in order to address organization business needs
  • Creates all destruction reports and coordinates pick ups for controlled destruction from MRB,

Supporting Responsibilities

  • Back up to State Licensing associate
  • Participates and represents department at project meetings as required

Education & Experience

  • Bachelor’s degree in a relevant field required
  • 2+ years’ relevant work experience
  • Experience with IQVIA SOM software preferred

Knowledge

  • Working knowledge of GMP regulations and compliance issues
  • Strong knowledge of DEA and FDA regulations
  • Knowledgeable of production and production planning processes

Skills & Abilities

  • Ability to work with individuals in a professional manner up or down the organizational ladder
  • Proficiency in the following software applications: MS Office, Access Database, Excel, TrackWise, Acrobat Professional and SAP
  • The ability to master new applications upon request
  • Strong work ethic, focused, able to prioritize workload with minimal supervision, detail-oriented, organization skills, able to multi‐task and follow‐up on open tasks; importantly, ability to execute on job functions in timely manner
  • Professionalism - Approaches others in tactful manner; reacts well under pressure; treats others with respect and consideration regardless of status or position; accepts responsibility for own actions; follows through on commitments
  • Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality
  • Adaptability - Adapts to changes in work environment; manages competing demands; changes approach or method to best fit situation; able to deal with frequent change, delays, or unexpected events
  • Initiative - Volunteers readily; Undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed
  • Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings
  • Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information

Physical Requirements

  • Ability to sit/stand in an office environment

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