Quality Assurance (QA) Associate

Medpace•Cincinnati, OH

38d•Onsite

About The Position

The successful candidate will be responsible for facilitating the management of sponsor audits, broad range of regulatory inspections (FDA, EMA, MHRA) and facilitating QA relationship with external clients. The position will also include conducting inspection readiness activities for Medpace and Medpace stakeholders.

Requirements

Bachelor's degree in science or a related field;
Strong communication skills;
Strong quality mindset;
Experience in supporting or conducting audits;
Excellent written and verbal communications skills in English;
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; and
The ability to work well on a team as well as independently.

Nice To Haves

Experience in conducting and supporting regulatory inspections is a plus (FDA, MHRA and EMA);

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;
Manage pre-inspection activities for Medpace inspections;
Provide inspection data trends to the Quality Metrics group for executive management review;
Manage the inspection backroom during regulatory inspections to facilitate the timely delivery of requested documents;
Conduct mock interviews for subject matter experts (SMEs) during inspection preparation;
Reviewing, and analyzing regulatory inspection data issued by regulatory authorities (e.g. MHRA, EMA, FDA);
Manage training for Medpace stakeholders with respect to inspection readiness;
Conducting inspection readiness visits at selected sites (as applicable) to assess inspection risk;
Act as QA lead for inspections at Medpace;
Provide as needed support for inspections at Medpace external clients (sponsors and investigator sites); and
Maintain the memorializing of frequently asked questions repository for regulatory inspection.