Medpace · 2 days ago
Quality Assurance (QA) Associate
Cincinnati, OH
Full-time
Onsite
New Grad, Entry LevelMedpace is a full-service clinical contract research organization (CRO) that provides clinical development services to the biotechnology, pharmaceutical, and medical device industries. The Quality Assurance (QA) Associate will facilitate the management of sponsor audits and regulatory inspections while conducting inspection readiness activities for Medpace and its stakeholders.
BiotechnologyPharmaceutical
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
Qualification
Required
Bachelor's degree in 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
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
Benefits
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
Company
Medpace
Medpace, Inc., a clinical research organization, provides clinical development services for pharmaceutical and biotechnology
Founded in 1992
5001-10000 employees
H1B Sponsorship
Medpace has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (29)
2024 (21)
2023 (19)
2022 (22)
2021 (22)
2020 (16)
Funding
Current Stage
Public CompanyTotal Funding
unknown2016-08-10IPO
2014-02-24Acquired
Leadership Team
J
Jesse Geige
President
Recent News
MarketScreener
2025-11-19
2025-10-27
2025-10-25
Company data provided by crunchbase