Senior QA Auditor (Pharmaceutical)

Location: Durham, North Carolina, United States of America

Salary: $75,400–$188,600 annual base pay

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Plan, schedule, conduct, report, and close independent audits across countries involved in hirify.global contracts.
• Evaluate audit findings and distribute reports to operations staff, management, customers, and supervisors.
• Provide consultation on regulations, guidelines, compliance status, policies, procedures, and corrective action plans.
• Manage quality issues and review investigations, root cause analyses, CAPA, and effectiveness check plans through closure.
• Host customer audits and mock regulatory inspections, and assist with regulatory facility inspections.
• Maintain eQMS audit lifecycle updates and lead or support quality and process improvement initiatives.

Requirements

• Bachelor's degree preferred, or an equivalent combination of education, training, and experience.
• At least 5 years of experience in pharmaceutical, technical, or related work, including 3 years in quality assurance.
• Experience with GxP and knowledge of pharmaceutical research and development processes and regulatory environments.
• Knowledge of quality assurance processes, procedures, word-processing, spreadsheet, and database applications.
• Strong problem-solving, risk analysis, negotiation, communication, organization, training, and interpersonal skills.
• Ability to work independently, manage multiple projects, and maintain effective relationships with colleagues, managers, and clients.

Culture & Benefits

• Full-time employment with potential incentive plans, bonuses, and other compensation.
• Health and welfare benefits may be available depending on the position offered.
• Work includes collaboration with operational staff, management, customers, and international project teams.
• Equal opportunity employment committed to integrity and compliance in the hiring process.