Quality Assurance (QA) Auditor

Medpace, Inc. • Cincinnati, OH

16h • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

• Medical Device and or Phase 1 experience is a plus.

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).

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level