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Laboratory Quality Assurance (Qa) Manager

Company

Medpace, Inc.
Address , Cincinnati, 45227
Employment type FULL_TIME
Salary
Expires 2023-09-21
Posted at 8 months ago
Job Description
Responsibilities :
  • Coordinating, conducting, and tracking Regulatory Training (GLP and ICH/GCP) on a company wide basis;
  • Coordinate, conduct and track company-wide Regulatory training and Quality Event Management;
  • Developing training materials and applicable tests and guides.
  • Host Audits/Inspections by Sponsors and Regulatory Inspectors in a Clinical Lab setting;
  • Management and oversight of departmental Standard Operating Procedures, forms and templates;
  • Manage Internal and External Laboratory related Audits according to current applicable Regulations;
  • Supervise QA Lab Auditors and Associates;
  • Conduct vendor audits;
  • Assisting QA leadership with departmental overview and development of QA Auditors; and
Qualifications :
  • Experience in conducting audits of vendors;
  • Excellent written and verbal communication skills.
  • Experience in hosting Regulatory Authorities and interacting with Sponsor/client representatives;
  • Independent thinking and planning ability; and
  • Past supervisory experience is preferred;
  • 3 - 5 years of experience in a lab setting in a related industry required;
  • Bachelor’s degree in Life Sciences or a related field;
  • Knowledge and application of GCP and GLP is required;
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 5,000 people across 40+ countries.
Why Medpace?:
People. Purpose. Passion. Make a Difference Tomorrow. Join Today

The work we’ve done over the past 30 years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Celebrates 30 Years
As we celebrate 3 decades of industry expertise and organic growth, we recognize the global team responsible for driving clinical development at Medpace. Click here to learn more about Medpace Celebrating 30 Years.
Cincinnati Perks
  • Modern, ecofriendly campus with an on-site fitness center, bar, and restaurants
  • Hybrid work-from-home options (dependent upon position and level)
  • Discounted tuition for UC online programs
  • Structured career paths with opportunities for professional growth
  • Cincinnati Campus Overview
  • Partnership and discount with onsite childcare
  • Employee health and wellness initiatives
  • Company-sponsored employee appreciation events
  • Community involvement with local nonprofit organizations
  • Flexible work hours
  • Competitive PTO packages, starting at 20+ days
  • Discounts on local sports games, local fitness gyms and attractions
    • Official Sponsor of FC Cincinnati
  • Competitive compensation and benefits package
  • Official Sponsor of FC Cincinnati

Awards:
  • Recognized by Forbes as one of America's Best Mid-size Companies in 2021 and 2022
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next:
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

EO/AA Employer M/F/Disability/Vets