Quality Assurance Laboratory Auditor

Created by: Medpace
Added: 25.06.2020

Advert description

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

  • 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.

 

Specific details

Type of Contract Full time
Preferred Education Bachelor's, Other
Level of Experience 2-5 years

Location

Belgium, Europe
Louvain