QA Auditor
MEDPACE
Leuven, Belgium
3 dagen geleden

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

Our European activities are growing rapidly, and we are currently seeking a full-time QA Auditor (up to senior level) to join our Quality Assurance team.

This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

  • Work as a trusted partner with Medpace operations to promote a culture of continuous improvement;
  • Coordinate and conduct internal system audits and external investigative site / vendor audits;
  • Create, maintain, and revise departmental Standard Operating Procedures, forms, and templates;
  • Coordinate, conduct, and track company-wide Regulatory Training (ICH / GCP, GLP, Medical Device);
  • Coordinate, conduct, track, and resolve company-wide Corrective Action / Preventative Action (CAPA) investigations;
  • Develop training materials and applicable tests and guides;
  • Work with outside clients / sponsors.
  • Qualifications

  • Bachelor’s degree in life sciences or nursing;
  • 1 or more years of experience in a QA department in a related industry;
  • Experience of GCP site audits;
  • Excellent written and verbal communication skills;
  • Exceptional teamwork skills; and
  • Ability to work independently.
  • Travel : Average of 50%

    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
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