Laboratory Quality Assurance (QA) Manager

Company: Medpace, Inc.
Location: Cincinnati
Posted on: June 25, 2022

Job Description:

Responsibilities :

• Manage Internal and External Laboratory related Audits according to current applicable Regulations;
• Coordinate, conduct and track company-wide Regulatory training and Quality Event Management;
• Management and oversight of departmental Standard Operating Procedures, forms and templates;
• Host Audits/Inspections by Sponsors and Regulatory Inspectors in a Clinical Lab setting;
• Conduct vendor audits;
• Coordinating, conducting, and tracking Regulatory Training (GLP and ICH/GCP) on a company wide basis;
• Supervise QA Lab Auditors and Associates;
• Assisting QA leadership with departmental overview and development of QA Auditors; and
• Developing training materials and applicable tests and guides.Qualifications :
  • Bachelor's degree in Life Sciences or a related field;
  • 3 - 5 years of experience in a lab setting in a related industry required;
  • Knowledge and application of GCP and GLP is required;
  • Past supervisory experience is preferred;
  • Experience in conducting audits of vendors;
  • Experience in hosting Regulatory Authorities and interacting with Sponsor/client representatives;
  • Independent thinking and planning ability; and
  • Excellent written and verbal communication 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 CincinnatiWhat 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

Keywords: Medpace, Inc., Cincinnati , Laboratory Quality Assurance (QA) Manager, Executive , Cincinnati, Ohio