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GCP Auditor

2 months ago

Nashville, Tennessee, United States MMS Full time
Job Overview

MMS is a leading clinical research organization (CRO) that prides itself on being a Great Place to Work certified organization. We are seeking a highly skilled GCP Auditor to join our team and contribute to our mission of shaping the future of clinical research.

Key Responsibilities
  • Conduct vendor qualification audits and/or investigator site audits, including the creation of audit plans, reports, and debrief presentations.
  • Provide vendor oversight and monitoring, as needed.
  • Investigate errors and conduct risk assessments.
  • 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.
What We Offer

MMS is a dynamic and supportive organization that values its employees. As a GCP Auditor, you will have the opportunity to work with a talented team and contribute to the success of our clients. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.