Closing Date: 22 Dec 16
Salary (£): Negotiable
SUMMARY OF POSITION Medpace, a rapidly growing global Contract Research Organization headquartered in Cincinnati, is seeking a Reference Laboratory Quality Assurance (QA) Auditor to join our global QA team. The QA Auditor will play an essential role in ensuring that Medpace upholds a standard for excellence at our various sites and global headquarters by providing accurate, consistent and reliable regulatory guidance. ...
SUMMARY OF POSITION
Medpace, a rapidly growing global Contract Research Organization headquartered in Cincinnati, is seeking a Reference Laboratory Quality Assurance (QA) Auditor to join our global QA team. The QA Auditor will play an essential role in ensuring that Medpace upholds a standard for excellence at our various sites and global headquarters by providing accurate, consistent and reliable regulatory guidance. This person will be experienced in Clinical Laboratory Improvement Amendments (CLIA) regulations and will report to the QA Manager. The position will be based in Leuven, Belgium.
DESCRIPTION OF JOB DUTIES
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 AND REQUIREMENTS
* Bachelor’s degree in the science or a related field
* Three or more years of experience in Quality Assurance
* Knowledge and application of GCP and GCLP is required
* Experience in conducting audits of in a laboratory environment
* Excellent written and verbal communications skills
* Independent thinking and planning ability
* Attention to detail
* The ability to work well on a team as well as independently.
Finding work that is challenging, where you are given the tools and training to succeed, where you are rewarded and are provided opportunities to grow professionally are just a few reasons talented individuals join the Medpace team.
WHAT TO EXPECT NEXT
We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.
5375 Medpace Way
|Tel:||+1 513 579 9911|
|Fax:||+1 513 579 0444|
|Website:||Visit Our Web Site|
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