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Laboratory Quality Assurance (QA) Associate

Laboratory Quality Assurance (QA) Associate

MedpaceCincinnati, OH, United States
3 days ago
Job type
  • Full-time
Job description

Job Summary

The successful candidate will be responsible for facilitating the management of sponsor audits, and facilitating QA relationship with external clients. The position will also include conducting inspection readiness activities for Medpace and Medpace stakeholders.

Responsibilities

  • Facilitating Medpace sponsor audits onsite;
  • Review and assess responses to sponsor audit reports;
  • Provide clarity to the Quality Management System (QMS) during sponsor audits and other external audits;
  • Provide guidance to Medpace study teams during sponsor audits; and
  • Manage pre-inspection activities for Medpace inspections.

Qualifications

  • Bachelor's degree in life science or a related field;
  • Experience in conducting and supporting regulatory inspections is a plus (FDA, MHRA and EMA);
  • Strong communication skills;
  • Strong quality mindset;
  • Excellent written and verbal communications skills;
  • Independent thinking and planning ability;
  • Experience with a wide range of computerized systems;
  • Good time management skills;
  • Ability to switch between both big picture view and attention to detail;
  • The ability to work well on a team as well as independently.
  • 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 Us 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.

    Cincinnati Perks

  • Cincinnati Campus Overview
  • Flexible work environment
  • Competitive PTO packages, starting at 20+ days
  • Competitive compensation and benefits package
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives
  • Community involvement with local nonprofit organizations
  • Discounts on local sports games, fitness gyms and attractions
  • Modern, ecofriendly campus with an on-site fitness center
  • Structured career paths with opportunities for professional growth
  • Discounted tuition for UC online programs
  • Awards

  • Named a Top Workplace in 2024 by The Cincinnati Enquirer
  • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
  • 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.

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    Quality Assurance Associate • Cincinnati, OH, United States

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