Quality Assurance Auditor

Overview

• Ensure compliance with FDA regulations through internal and external audits, supporting quality assurance initiatives and maintaining supplier qualification programs.
• Develop and implement performance tracking systems to monitor departmental compliance and prioritize corrective actions effectively.
• Collaborate with internal departments to enhance understanding of quality and compliance expectations and support regulatory inspection readiness.
• Manage audit documentation and vendor-related records within a Quality Management System (QMS).
• Conduct risk assessments for audit findings and ensure appropriate corrective and preventive actions are implemented.
• Provide quality assurance support for product development, investigations, and corrective actions as required.
• Travel domestically for audits, ensuring compliance to regulations and standards.
• Train and assist teams in adhering to quality assurance processes and policies.

Key Responsibilities & Duties

• Plan, schedule, and conduct internal and external audits to assess compliance with FDA regulations and company standards.
• Maintain supplier qualification programs, including managing approved vendor lists and corrective action requests.
• Oversee external vendors responsible for international audits and ensure adherence to compliance requirements.
• Develop and implement tracking systems for audit performance metrics and departmental compliance reporting.
• Support training initiatives to prepare for regulatory inspections and enhance organizational compliance readiness.
• Communicate audit findings and compliance metrics effectively across all organizational levels.
• Assist in the development and execution of processes or policies to mitigate compliance risks.
• Perform quality assurance functions in SAP and other software tools as needed.

Job Requirements

• Bachelor's degree in Science or a technical field is required.
• Minimum of 5 years of quality assurance auditing experience in a cGMP environment.
• Experience with external vendor/supplier compliance auditing within FDA-regulated industries.
• Knowledge of FDA regulations 21 CFR Parts 210, 211, 507, and 111.
• ASQ Certified Auditor (CQA) certification is preferred.
• Proficiency in computer software applications, including MS Office Suite and SAP.
• Ability to travel domestically 20-30% for audits on short notice.
• Strong communication skills and ability to work in a team environment.