GCP QA Auditor

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 ourQuality Assurancedepartment, whose success relies upon on the finely tuned skills and background of our QA Auditors.

• 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);

• 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.