Quality Assurance (QA) Auditor

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) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?:

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

• • Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

• • Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
  • Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development

• • Office based environment with on-site mentors
  • Defined career paths with clear advancement opportunities
  • Industry renowned onboarding and training programs designed to accelerate professional development
  • Ongoing training and continuous learning opportunities throughout your career
  • An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

• • Competitive compensation programs that recognize and reward performance
  • Comprehensive health, wellness, retirement, and PTO benefits
  • Office based culture with occasional WFH that provides flexibility for eligible positions after training
  • Company-sponsored social events and intramural sports

Cincinnati Headquarters Experience

• • A modern corporate campus designed to support collaboration and productivity
  • Multiple on-site dining options in the heart of Madison Square
  • Free on-site parking
  • Convenient access to on-site 24-7 fitness and wellness facilities

What to Expect Next

A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.