Quality Assurance (QA) Associate

Medpace, Inc.•Cincinnati, OH

5d•Hybrid

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 Life Sciences or a related field
Experience in conducting and supporting regulatory inspections is a plus (FDA, MHRA and EMA)
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
The ability to work well on a team as well as independently

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)
Maintain the memorializing of frequently asked questions repository for regulatory inspection