Summary
Overview
Work History
Education
Skills
Timeline
Generic

Shanti R. Hinsberg

Chandler,AZ

Summary

Highly skilled and experienced professional with over 20 years of expertise in leading and conducting controlled substance audits, identifying risks, systemic gaps, and trends. Seeking a challenging position where I can utilize my knowledge and contribute to the development and enhancement of robust controlled substance programs across diverse networks. Committed to delivering impactful training programs to elevate knowledge and proficiency in the management of controlled substances across multiple regions.

Overview

14
14
years of professional experience

Work History

Sr. Quality Specialist

Thermo Fisher Scientific Inc.
09.2022 - Current
  • Perform audits, gap assessments, and related projects to assess the level of quality and regulatory compliance within the controlled substance program
  • Conduct quality management reviews of technical documentation
  • Monitor, assess, and ascertain the efficacy of corrective and/or preventive actions
  • Analyze audit data, identify systemic compliance issues or gaps, trends, and propose risk mitigation strategies

Regulatory Compliance Specialist

Cue Health, Inc
03.2022 - 09.2022
  • Contribute to the formulation and implementation of comprehensive internal and external audit procedures
  • Provide support for compliance audits, risk assessments, and ongoing compliance monitoring activities
  • Coordinate the thorough review and resolution of issues and concerns
  • Support the development and implementation of compliance educational programs

DEA Compliance Audit Manager

Independent Pharmacy Consultant (IPC)
02.2014 - 02.2022
  • Conduct on-site audits of independent pharmacies
  • Oversee and monitor controlled drug purchases made by customers within the controlled substance program
  • Manage and maintain IPC's Suspicious Order Monitoring (SOM) system
  • Investigate allegations of pharmacy non-compliance and take appropriate action
  • Collaborate with pharmacy owners to identify and address potential regulatory issues
  • Design and execute comprehensive internal audits of the controlled substances program
  • Draft and update controlled substance Standard Operating Procedures (SOP)
  • Prepare and submit regulatory documentation to the DEA

Risk Management Paralegal

Banner Health
09.2013 - 02.2014
  • Review and analyze incoming documentation related to complex claim matters, pre-litigation cases, and medical malpractice non-litigation discovery documents
  • Collaborate with external defense counsel to coordinate witness interviews and facilitate court appearances
  • Conduct comprehensive reviews of specific physician and non-physician-related contracts
  • Participate in site viewings and attend medical malpractice non-litigation depositions and settlement conferences

Compliance Paralegal

Insight Enterprises
06.2010 - 06.2013
  • Assess and interpret export control compliance mandates in accordance with governmental regulations
  • Perform internal audits to evaluate compliance with export-related documentation, processes, and protocols
  • Provide comprehensive compliance assistance to the HR department
  • Oversee new hire training and annual compliance training for a global workforce of over 5,000 employees

Education

MBA - Business Administration

University of Phoenix
Tempe, AZ
10.2002

Bachelor of Arts - Political Science

Arizona State University
Tempe, AZ
05.1996

Skills

  • Proven track record of delivering impactful training programs
  • Expertise in identifying risks, systemic gaps, and trends
  • CAPA Management
  • Extensive expertise and knowledge in compliance with the US Drug Enforcement Administration (DEA), European Union Controlled Drug Regulations, Health Canada Controlled Drugs and Substances Act, and other international controlled drug regulations
  • Knowledge and familiarity with key regulatory frameworks including US FDA CFR, European Medical Device Directives (MDD, IVDD, AIMD), European Regulations (MDR, IVDR), Medical Device Single Audit Program (MDSAP), and international quality system standards such as ISO 9001 and 13485

Timeline

Sr. Quality Specialist

Thermo Fisher Scientific Inc.
09.2022 - Current

Regulatory Compliance Specialist

Cue Health, Inc
03.2022 - 09.2022

DEA Compliance Audit Manager

Independent Pharmacy Consultant (IPC)
02.2014 - 02.2022

Risk Management Paralegal

Banner Health
09.2013 - 02.2014

Compliance Paralegal

Insight Enterprises
06.2010 - 06.2013

MBA - Business Administration

University of Phoenix

Bachelor of Arts - Political Science

Arizona State University

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Shanti R. Hinsberg