GCP Auditor

4 weeks ago

Canton, Michigan, United States MMS Full time
Job Overview

MMS, a leading clinical research organization, is seeking a highly skilled GCP Auditor to join our team. As a GCP Auditor, you will play a critical role in ensuring the integrity and quality of our clinical trials.

Key Responsibilities
  • Conduct vendor qualification audits and investigator site audits, including the preparation of audit plans, reports, and debrief presentations.
  • Provide oversight and monitoring of vendors as needed.
  • Investigate errors and conduct risk assessments to ensure compliance with regulatory requirements.
  • Host and interact with regulatory authorities during inspections.
Requirements
  • Minimum 5 years of experience in GCP auditing within the CRO, Pharma, or Biotech industry.
  • Bachelor's Degree in a scientific, medical, or clinical discipline.
  • Travel may be required for onsite audits.
  • Expert knowledge of scientific principles and concepts.
  • Proficiency with MS Office applications.
  • Hands-on experience with clinical trial and pharmaceutical development.
  • Excellent communication and problem-solving skills.
  • Good organizational and communication skills.
  • Familiarity with current ISO 9001 and ISO 27001 standards.
  • Proficient experience with 21 CFR Part 11, FDA, and GCP requirements.
  • Basic understanding of CROs and scientific and clinical data/terminology, and the drug development process.