# Quality Assurance Auditor **Company**: IQVIA **Location**: Durham, North Carolina **Experience**: senior **Job type**: full-time **Salary**: $75,400.00 - $188,600.00 **Category**: Healthcare **Industry**: Healthcare **Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Durham-North-Carolina-United-States-of-America/Sr-QA-Auditor---41779_R1517454?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_07be9cfc-5e4 ## Description We are seeking a Quality Assurance Auditor to plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. You will prepare and distribute reports of findings to supervisor, operations staff, management, and customers. As a Quality Assurance Auditor, you will provide consultation in interpretation of regulations, guidelines, policies, and procedures, and support management in promotion and assessment of compliance to regulations, guidelines, and corporate policies. **Responsibilities** - Plan, schedule, conduct, report, and close audit activities in various countries to assess compliance with applicable regulations, guidelines, customer requirements, IQVIA SOPs, and project-specific guidelines/instructions - Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers - Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, policies, and procedures - Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans - Manage Quality Issues - Present educational programs and provide guidance to operational staff on compliance procedures - Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA), and Effectiveness Check (EC) plans, and track until closure for quality events arising from Quality Issues, Audits, Inspections, or similar QA activities - Provide quality assurance consultancy activities and projects for clients within budget and established timelines - Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements - Host audits/inspections, ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections - Perform GLP Archivist duties where needed - Manage/oversee quality events updates in eQMS and/or maintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle - Lead/collaborate/support in QA initiatives/projects for quality, process improvements - Assist in training of new Quality Assurance staff **Qualifications** - Bachelor's Degree preferred - 5 years of experience in pharmaceutical, technical, or related area, with 3 years in Quality Assurance and GXP experience - Knowledge of word-processing, spreadsheet, and database applications - Extensive knowledge of pharmaceutical research and development processes and regulatory environments - Knowledge of quality assurance processes and procedures - Strong interpersonal skills - Excellent problem-solving, risk analysis, and negotiation skills - Strong training capabilities - Effective organization, communication, and team orientation skills - Ability to initiate assigned tasks and work independently - Ability to manage multiple projects - Ability to establish and maintain effective working relationships with coworkers, managers, and clients ## Skills ### Required - GXP - quality assurance - regulatory compliance - audit planning - report writing - consultation - training - team collaboration - project management - risk analysis - negotiation --- Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Durham-North-Carolina-United-States-of-America/Sr-QA-Auditor---41779_R1517454?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)