QA Auditor 2

Overview

QA Auditor 2 conducts and supports quality audits, manages quality issues and CAPA plans, and provides GXP compliance consultation across IQVIA contracts.

What you'll do

• Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations, guidelines, customer requirements, SOPs and project-specific guidelines.
• 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 interpreting audit observations.
• Host customer-initiated audits, mock regulatory inspections and regulatory facility inspections, and perform GLP Archivist duties where needed.
• Review and approve investigations, root cause analyses (RCA), CAPA and effectiveness check (EC) plans, and track quality events to closure.
• Manage and oversee quality event updates in the eQMS and maintain the eQMS, supporting the audit lifecycle.
• Present educational programs and guidance to operational staff on compliance procedures.
• Provide quality assurance consultancy activities and projects for clients within budget and timelines.
• Evaluate policies and procedures for compliance and recommend continuous process improvements to management.
• Assist in training new Quality Assurance staff and support QA initiatives and projects for quality and process improvement.

What you'll need

• Bachelor's degree or equivalent combination of education, training and experience.
• 4+ years of experience in pharmaceutical, technical, or related areas, including GXP and/or Quality Assurance experience.
• Knowledge of word-processing, spreadsheet and database applications.
• Considerable knowledge of GXP regulations and quality assurance auditing techniques.
• Strong interpersonal skills and excellent problem-solving skills.
• 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.

Nice to have

• Bachelor's degree.
• 4+ years of experience in pharmaceutical, technical, or related areas including GXP and/or Quality Assurance experience.