Quality Assurance (QA) Associate
Medpace
Cincinnati, OH0–2 yrs1h agovia LinkedIn
About the Role
The Quality Assurance (QA) Associate facilitates the management of sponsor audits, a broad range of regulatory inspections (FDA, EMA, MHRA), and QA relationships with external clients. This position also includes conducting inspection readiness activities for Medpace and Medpace stakeholders.
Key Responsibilities
- Facilitate 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.
- Review and analyze regulatory inspection data issued by regulatory authorities (e.g., MHRA, EMA, FDA).
- Manage training for Medpace stakeholders with respect to inspection readiness.
- Conduct 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.
Qualifications
- Bachelor’s degree in Life Sciences or a related field.
- Experience in conducting and supporting regulatory inspections is a plus (FDA, MHRA, 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.
- Ability to work well on a team as well as independently.