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GCP QA Auditor Job in Cincinnati, Ohio US
Monster
 
 
 
 

Job Summary

Company
Medpace, Inc.
Location
Cincinnati, OH
Industries
Government and Military
Job Type
Full Time
Employee
Years of Experience
1+ to 2 Years
Job Reference Code
82196309_1

GCP QA Auditor

About the Job

GCP QA Auditor


Job Locations

United States-OH-Cincinnati




Category

Quality Assurance


Job Summary




Due to our rapid growth we need experienced industry professionals to join our Quality Assurance (QA) team. This position will support and audit global trials in a variety of therapeutic areas, maintaining organizational and regulatory standards throughout our company. This is a vital role in our Quality Assurance department, whose success relies upon on the finely tuned skills and background of our QA Auditors.


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);


Qualifications




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;
Medical Device and or Phase 1 experience is a plus;
Ability to travel up to 30%-40% of time;
Excellent written and verbal communication skills;
Exceptional teamwork skills; and
Ability to work independently.


Medpace Overview




Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.


Why Medpace?




People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Cincinnati Perks

Cincinnati Campus Overview
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

Awards

Named a Top Workplace in 2024 by The Cincinnati Enquirer

Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility



What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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