GCP QA Auditor jobs in United States
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Medpace · 1 day ago

GCP QA Auditor

positionCincinnati, OH
timeFull-time
remoteHybrid
seniorityEntry, Mid Level
date2+ years exp

Medpace is a full-service clinical contract research organization (CRO) that provides Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. The GCP QA Auditor will support and audit global trials, ensuring compliance with organizational and regulatory standards while developing audit management plans and conducting audits according to Good Clinical Practice (GCP) guidelines.

BiotechnologyPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Act as a Quality Program Lead on clinical trials by supporting national and international regulatory standards and guidance for pharmaceuticals, biologics and medical devices
Develop audit management plans and audit strategy with clients for ongoing clinical trials
Coordinate and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines
Participate in the development of departmental standard operating procedures, work instructions, forms, and templates
Assess validated state and security of proprietary and cloud based software
Develop training materials and applicable interactive tests and proficiency training including company-wide regulatory training (ICH/GCP)

Qualification

Clinical Practice (GCP)Quality Assurance (QA) experienceAudit managementMedical Device experienceIndependent working abilityCommunication skillsTeamwork skills

Required

Bachelor's degree in life sciences or related field
2-5 years of experience in a QA department in a related industry
Experience conducting audits of vendors and investigative sites
Experience hosting regulatory authorities and interacting with sponsor/client representatives
Independent thinking and planning ability
Knowledge and application of Good Clinical Practice (GCP) is required
Ability to travel up to 30%-40% of time
Excellent written and verbal communication skills
Exceptional teamwork skills
Ability to work independently

Preferred

Medical Device and or Phase 1 experience is a plus

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

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Medpace, Inc., a clinical research organization, provides clinical development services for pharmaceutical and biotechnology
dateFounded in 1992
location
Cincinnati, Ohio, USA
people-size5001-10000 employees
web-link
http://www.medpace.com

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 Company
Total Funding
unknown
2016-08-10IPO
2014-02-24Acquired

Leadership Team

J
Jesse Geige
President
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Recent News

MarketScreener
Medpace: From Q3 25 success to future horizons
2025-11-19
thefly.com
Medpace price target raised by $119 at Truist, here's why
2025-10-27
Benzinga.com
Medpace Analysts Increase Their Forecasts After Upbeat Q3 Earnings
2025-10-25
Company data provided by crunchbase