Quality Assurance Auditor, DMB

Responsibilities

• Carry out auditing of study, project, and process reports, records and data; report audit findings to operations via QA audit reports; and determine acceptability of the responses and verify the corrections (includes but not limited to 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; and maintain effective and professional working relationships within and across departments in relation to study projects.
• Participate and lead in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes.
• Detect quality issues and 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

Qualifications

• Bachelor’s degree in science, IT, business, or similar
• 2-5 years of quality/laboratory/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…