Responsibilities Carry out auditing of study, project, and process reports, records and data; report audit findings to operations via QA audit reports; determine acceptability of responses and verify corrections (including Clinical Study Report audits, Protocol audits and Electronic Database Capture (EDC) audits). Interact with internal and external clients to discuss QA observations and study‑related issues; maintain effective and professional working relationships within and across departments in relation to study projects. Participate and lead in improvement initiatives to enhance quality, compliance of study, project data and reports, and to increase process effectiveness and efficiency. Detect quality issues, identify the need for CAPAs, and evaluate deviations. Assist with the preparation for and hosting of client audits and/or regulatory inspections. Participate in the preparation, conduct, and follow‑up for System Audits and Vendor Audits. Requirements Bachelor’s degree in science, IT, business, or similar. 2-5 years of quality, laboratory, or clinical experience. Excellent oral and written communication skills. Ability to organize and manage multiple priorities. Excellent time management skills. Attention to detail, tactful, and diplomatic. Proficiency in using electronic data and computerized systems. Ability to travel, as needed. #J-18808-Ljbffr
Quality Assurance Auditor • Buffalo, NY, United States
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