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GCP Quality Assurance (QA) Auditor

Company: Medpace
Location: Wilmington
Posted on: March 21, 2020

Job Description:

Overview

Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace's mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,700 people across 36 countries.

Job Summary

Due to our rapid growth we need experienced industry professionals to join our Quality Assurance (QA) tea m. This position will support and audit global trials in a variety of therapeutic areas, maintaining organizational and regulatory standards throughout our company. This is a vital role in our Quality Assurance department, whose success relies upon on the finely tuned skills and background of our QA Auditors.

Responsibilities

  • Coordinate and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines;
  • Create, maintain, and revise departmental standard operating procedures, forms, and templates;
  • Host audits by sponsors and regulatory inspectors;
  • Coordinate, conduct, and track company-wide regulatory training (ICH/GCP and medical device);
  • Develop training materials and applicable tests and guides; and
  • Work with outside clients/sponsors.Qualifications
    • Bachelor's degree in life sciences or related field;
    • 2-5 years of experience in a QA department in a related industry;
    • Experience conducting audits of vendors and investigative sites;
    • Experience hosting regulatory authorities and interacting with sponsor/client representatives;
    • Independent thinking and planning ability;
    • Knowledge and application of Good Clinical Practice (GCP) is required;
    • Medical Device and or Phase 1 experience is a plus;
    • Ability to travel up to 30%-40% of time;
    • Excellent written and verbal communication skills;
    • Exceptional teamwork skills; and
    • Ability to work independently. Why Medpace?

      When you join Medpace, you become part of a team dedicated to supporting the development of ground breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

      Awards
      • Medpace Named a Top Cincinnati Workplace for 2015, 2016, 2017 and 2018 by the Cincinnati Enquirer
      • Winner of the ACRP-Avoca CRO Quality Award in 2018
      • Recognized with six CRO Leadership Awards from Life Science Leader magazine
      • Eagle Award winner - which recognizes outstanding leadership, professionalism, integrity, and dedication to advancing the clinical research profession through strong site partnerships What to Expect Next

        We look forward to receiving your application. A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.

        EO/AA Employer M/F/Disability/Vets

        *WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.

Keywords: Medpace, Wilmington , GCP Quality Assurance (QA) Auditor, Accounting, Auditing , Wilmington, North Carolina

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