Summary
Overview
Work History
Education
Skills
Timeline
Generic

Rochelle Kimmel

Teaneck

Summary

Results-driven compliance professional with a proven track record of navigating complex regulatory landscapes to ensure organizational adherence to legal standards. Strong focus on team collaboration while delivering reliable compliance solutions and adapting seamlessly to dynamic environments. Expertise includes risk assessment, policy development, and regulatory reporting, complemented by a proactive and analytical approach to problem-solving. Committed to fostering a culture of compliance that exceeds industry expectations.

Overview

24
24
years of professional experience

Work History

Compliance Consultant

Global Compliance Services, LTD
Brooklyn, NY
06.2007 - 07.2014
  • Designed and implemented compliance frameworks to uphold regulatory standards and mitigate risks.
  • Analyzed compliance frameworks through risk assessments and gap analyses to uncover potential vulnerabilities.
  • Conducted comprehensive training sessions to ensure staff adherence to compliance policies and procedures.
  • Engaged with various departments to refine compliance procedures, resulting in improved efficiency.
  • Developed compliance frameworks to align with regulatory standards and industry best practices.
  • Conducted thorough evaluations of food product labels to ensure compliance with FDA standards.

Director, GMP Audits & Documentation

Taro Pharmaceuticals
Elmsford, NY
02.2002 - 06.2007
  • Managed compliance processes to uphold industry standards and promote best practices within the organization.
  • Conducted thorough evaluations of policies and procedures to ensure compliance with regulatory requirements.
  • Proactively assessed potential risks and developed strategies to minimize adverse effects on project outcomes.
  • Oversaw regulatory compliance processes, ensuring adherence to industry standards and best practices.
  • Strengthened internal controls by reviewing existing policies and procedures, ensuring compliance with regulatory requirements.
  • Proactively identified potential risks and implemented mitigation strategies to minimize negative impacts on projects or business operations.
  • Facilitated FDA inspections by coordinating team efforts and maintaining documentation for compliance verification.

FDA Consumer Safety Investigator

Food And Drug Administration
Rockville, MD
03.1990 - 02.2002
  • Evaluated various food product labels to ensure compliance with FDA regulations.
  • Conducted and Managed audits and operational assessments of domestic and international pharmaceutical manufacturers of diverse finished dosage forms, as well as chemical synthesis and fermentation of Active Pharmaceutical Ingredients (APIs).
  • Evaluated and /Wrote Recommendations of regulatory actions and policy responses to be taken by the FDA.
  • Compliance policies
  • SOPs
  • Responses to Inspectional Observations (FDA 483s);
  • Consultant on corporate quality matters.
  • Advisor and trainer to senior management, operating personnel, R&D and QA/QC on matters relating to quality compliance issues and regulatory matters regarding operational compliance.
  • Training:
  • Compliance
  • GMPs
  • Regulatory Guidance Programs
  • Inspection preparation
  • Standard Operating Procedures
  • Ensure compliance with International cGMPs of country of manufacture and country of export (where product eventually sold).
  • Guidance provided to resolve quality incidents in manufacturing, packaging, analytical, etc.
  • Confirm incidents are accurately documented in written reports and correspondence, as required.
  • Ensure efficient transition of product from R & D to production process.

Education

Master of Science - Cosmetic Science

School of Pharmacy At St. Johns University
Jamaica, New York
06-1987

Bachelor of Arts - Chemistry

Alfred University
Alfred, New York
06-1967

Skills

  • Regulatory assessment expertise
  • Quality assurance in documentation
  • Compliance assessment and evaluation

Timeline

Compliance Consultant

Global Compliance Services, LTD
06.2007 - 07.2014

Director, GMP Audits & Documentation

Taro Pharmaceuticals
02.2002 - 06.2007

FDA Consumer Safety Investigator

Food And Drug Administration
03.1990 - 02.2002

Master of Science - Cosmetic Science

School of Pharmacy At St. Johns University

Bachelor of Arts - Chemistry

Alfred University

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