Laboratory Quality Assurance Auditor
il y a 4 jours
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:
- 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:
- Minimumb 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.
**Organic Growth**:
***Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarter's campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO.
**Perks (**
**_vary by location and position_**
**)**:
- On-site fitness center(s)
- Campus walking paths
- Company-sponsored social and wellness events
- Official Sponsor of FC Cincinnati
- Hybrid work-from-home options and flexible work schedule
- On-site Market Place
- Free and covered parking
- Discounts for local businesses
- On campus restaurants and banks coming soon
**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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