Internal Auditor

The Quality Internal Auditor is responsible for ensuring compliance with GMPs, FDA regulations, and other applicable laws. They conduct audits, present findings, and recommend changes to procedures or practices. They assist with inspection readiness for third-party and regulatory audits, develop audit programs and standard operating procedures, and manage the audit management system. They also analyze risks, review progress on audit findings, and ensure timely completion of commitments. Additionally, they assist with change controls, CAPAs, and deviations.

• Ensure compliance with quality systems, processes, and good manufacturing practices
• Conduct audits and present findings, recommending changes to procedures or practices that are not in compliance
• Provide technical assistance to implement changes as needed
• Assist with inspection readiness activities for third-party and regulatory audits
• Assist in the development of programs, workflows, and standard operating procedures for the Internal Audit program
• Manage the cloud-based audit management system
• Schedule and conduct internal audits
• Assist in managing and maintaining the Supplier qualification program, including associated documentation, approved supplier list, and risk assessments
• Prepare and review audit reports
• Analyze potential risks within the facility to avoid compliance issues
• Review progress toward closure of audit findings and report progress to appropriate management
• Perform follow-up on supplied information to verify corrective actions and CAPAs
• Ensure timely completion of commitments from regulatory agency inspections and partner audits
• Assist in completing department-related Change Controls, CAPAs, and Deviations as needed
• Review and evaluate internal responses to determine acceptability and applicable CAPA plans

• Ensure compliance with GMPs, FDA Regulations and Guidelines, and state, federal, and local laws
• Conduct audits and present findings
• Recommend changes to procedures or practices that are not in compliance
• Assist with inspection readiness for third party and regulatory audits
• Assist in the development of programs, workflows, and standard operating procedures for the Internal Audit program
• Manage cloud-based audit management system
• Schedule and conduct internal audits
• Assist in managing and maintaining the Supplier qualification program
• Prepare and review audit reports
• Analyze potential risks within the facility to avoid compliance issues
• Review progress toward closure of audit findings and report to management
• Perform verification checks on proposed corrective actions and CAPAs
• Ensure timely completion of commitments from regulatory agency inspections and partner audits
• Assist in completing department related Change Controls, CAPAs, and Deviations
• Review and evaluate internal responses and CAPA plans

• Relocation support for candidates requiring a move to Allerton, IA
• Discretionary performance-based annual cash bonus
• Participation in the company's equity program
• Robust medical, dental, vision, retirement, and other benefits