The Judge Group is working with a leading, growing biotechnology client in PA (Downingtown area) and has an exciting opportunity for a Clinical Quality Assurance Auditor. In this position the incumbent shall support GCP audits of Phase I  III domestic and international clinical research trials to assure compliance with all applicable government regulations, federal guidelines, company standard operating procedures, and industry standards. Audits will be performed on external investigator sites, vendors/CROs, trial master files (TMFs), data/CRFs, and study reports for clinical trials. In addition, the incumbent shall support the development; revision of GCP related SOPs as well as provides support for BLA preparations and the development and implementation of the Inspection Awareness/Readiness program.  Travel Requirement approximately 5%.

For immediate consideration please email your resume to mkk@judge.com.  There is no relocation for this role; must reside locally in PA. 

Essential Functions
Provide support for the development and implementation of the Inspection Awareness/Readiness Program
Support the development and revision of GCP related SOPs
Reviews audit responses for acceptability; elevates issues that are above incumbents abilities or that cannot be resolved
Recommends corrective action to compliance issues and/or observations as needed to insure corrective action is implemented
Monitors clinical operations corrective action process to insure corrective actions are being applied
Other projects and responsibilities may be added at the company discretion

Knowledge/Skills/Abilities Required
BA/BS degree in biological sciences, nursing or related discipline, or equivalent experience required with a minimum of 3 years working experience as a clinical quality assurance auditor
Strong knowledge of government regulations, guidelines and standards for investigation of new pharmaceutical products is required
Preferred experience in QA audits of Clinical Investigators and/or GCP System/Process Audits
Working knowledge and understanding of drug development and global clinical regulatory environment
Effective organizational skills
Effective team player and detail oriented
Strong attention to detail, good organizational skills, ability to work independently
Solid oral and written communication skills with ability to communicate effectively and professionally with medical personnel
Knowledge of the code of federal regulations, European Directives, ICH/GCP practices
Previous participation in regulatory inspections