Specialist, DEA Compliance

Strides Pharma Inc•Chestnut Ridge, NY

About The Position

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

Requirements

Bachelor’s degree in a relevant field required
4+ years’ relevant work experience
Working knowledge of GMP regulations and compliance issues
Strong knowledge of DEA and FDA regulations
Knowledgeable of production and production planning processes
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

Nice To Haves

Experience with IQVIA SOM software preferred

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