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Job Details

Laboratory Quality Assurance Auditor

Company: Medpace
Location: Leuven
Reference: 2016-1761
Closing Date: 22 Dec 16
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

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. ...

Requirements:

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.

WHY MEDPACE?

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.

Apply for this job: Laboratory Quality Assurance Auditor

Contact Information:

Address:  Medpace, Inc
5375 Medpace Way
Cincinnati
Ohio
45227
USA
Tel:  +1 513 579 9911
Fax:  +1 513 579 0444
Website:  Visit Our Web Site

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