Laboratory Quality Assurance Auditor

☞ Medpace

看过: 185

更新日: 26-11-2025

位置: Leuven Flemish Brabant

类别: 质量保证/质量控制

行业: Biotechnology Research

水平: Associate

工作类型: Full-time

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工作内容

Job Summary

Medpace is a global, full-service Contract Research Organization (CRO) headquartered in Cincinnati, Ohio, and active in over 40 countries across the globe. We are looking to strengthen the Global Quality Assurance team with a Quality Assurance (QA) Auditor at Medpace Reference Laboratories. The QA Auditor will play an essential role in ensuring that Medpace upholds a standard for excellence by providing accurate, consistent and reliable regulatory guidance. This position will report to the QA Manager, and will be based at Medpace Reference Laboratories in Leuven, Belgium.

Responsibilities

Job duties will be adjusted based on experience and expertise of the candidate, and may include
  • Coordinating and conducting internal process audits and external vendor audits;
  • Conducting Instrument Qualification and Method Validation audits;
  • Hosting external sponsor audits and regulatory/accreditation (e.g. CAPA) inspections;
  • Facilitating laboratory metrics, analysis and reporting;
  • Developing, conducting, and tracking company-wide applicable regulatory training;
  • Facilitating Quality Event Management, including investigation, root cause analysis, CAPA development, effectiveness checks, tracking and trending of Quality Events;
  • Support with maintenance and development of a risk based Quality Management System, including creation, revision or periodic review of Standard Operating Procedures;
  • Support to continuous process improvement;
  • Act as a consultant for laboratory personnel
Qualifications
  • Minimum Bachelor’s degree in the science or a related field
  • One or more years of experience in a GxP regulated industry (GCP, GCLP, GLP, GMP)
  • Experience in Quality Assurance is a plus
  • Good regulatory Knowledge (GCP, GLP or GCLP)
  • Experience in supporting or conducting audits in a laboratory environment
  • Excellent written and verbal communications skills in Dutch and English
  • Independent thinking and planning ability
  • Experience with a wide range of computerized systems
  • Good time management skills.
Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 4,000 people across almost 40 countries.

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 historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
  • Recognized by Forbes as one of America’s Best Mid-size Companies in 2021
  • Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
  • Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati
What To Expect Next

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
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最后期限: 10-01-2026

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