Quality Assurance Auditor II EnVivo Pharmaceuticals
THIS JOB HAS EXPIRED Job Objectives and Tasks:
Develops audit plans to ensure all clinical trials are conducted in compliance with the study protocol, site procedures, and all applicable regulatory requirements Conducts CQA audits of clinical sites, clinical quality systems, clinical vendors and regulatory documents to ensure clinical trials are conducted per Good Clinical Practice (GCP) requirements. Ensures that all audits are followed-up and corrective actions are completed, implemented, and verified Auditing of regulatory submission documents, including Clinical Study Reports and other essential documents (Protocol, Informed Consent Form, and Trial Master Files). Assists in the development of metric reports to QA management of all issues related to the outcome of the audits.
Minimum BA/BS Degree in biological sciences, nursing or related field
Excellent working knowledge and understanding of GCP-related requirements, including proficiency in US regulations and ICH guidelines for the conduct of clinical trials.
Strong clinical development background preferred, but not required.
Strong written and oral communication skills
Ability to be independent and self-disciplined, allowing for timely audit report submission and follow up.
Up to 40% travel may be required
Minimum of 5 years of clinical auditing experience with a demonstrated practical experience in Clinical QA for the pharmaceutical industry
Conduct and/or coordination of international Phase III site audits preferred.
Experience preparing sites and/or supporting sites during and after FDA or other international regulatory inspections, required.
||480 Arsenal Street |
Watertown, MA 02472
THIS JOB HAS EXPIRED