Home-Based Senior Clinical Quality Assurance Auditor

Medpace - United States (30+ days ago)2.5


Overview

Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,500 people across 35 countries.

Responsibilities
Medpace is a Clinical Research Organization that is rapidly growing across the globe. Due to our continued growth, we are in need of qualified and focused individuals, like yourself, for home-based and office-based positions. This position will only be home-based for individuals with a high level of QA experience. This is a vital role in our Quality Assurance department whose success relies upon your finely tuned skills and background. If you are ready to make a difference, you must be able to accomplish these tasks:

Coordinate and conduct internal system audits and external investigative site/vendor audits;
Create, maintain, and revise departmental standard operating procedures, forms, and templates;
Host audits by sponsors and regulatory inspectors;
Coordinate, conduct, and track company-wide regulatory training (ICH/GCP and medical device);
Develop training materials and applicable tests and guides;
Work with outside clients/sponsors; and
Other items as deemed necessary.
Qualifications

Bachelor’s degree in life sciences;
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 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.
WHY MEDPACE?

When you join Medpace, you become part of a team dedicated to supporting the development of ground breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

AWARDS

Medpace Named a Top Cincinnati Workplace for 2015, 2016 and 2017 by the Cincinnati Enquirer
Winner of the ACRP-Avoca CRO Quality Award in 2018
Eagle Award winner - which recognizes outstanding leadership, professionalism, integrity, and dedication to advancing the clinical research profession through strong site partnerships.

WHAT TO EXPECT NEXT

We look forward to receiving your application. A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.

EO/AA Employer M/F/Disability/Vets

  • WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.