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Sr. GCP QA Auditor - Remote

Company: Medpace
Location: Raleigh
Posted on: June 25, 2022

Job Description:

Start a career with one of the world's leading
Clinical Research Organizations. 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 approximately 3,500 people across almost 40 countries. Job Summary Due to our rapid growth we need experienced industry professionals to join our Quality Assurance (QA) tea m. 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;
    • 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. 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 historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
      • Recognized by Forbes as one of America's Best Mid-size Companies in 2021
      • Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
      • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next: 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. Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.

Keywords: Medpace, Raleigh , Sr. GCP QA Auditor - Remote, Accounting, Auditing , Raleigh, North Carolina

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