Quality Assurance Auditor I

Role: Quality Assurance Auditor within GLP-regulated environments, focusing on audits of studies, facilities, and compliance with FDA, EPA, and international GLP standards. Responsibilities: conduct facility and process audits, review documentation, prepare audit reports, support validation assessments, and assist with regulatory inspections. Requirements: Bachelor’s degree in chemistry, life sciences, or related field; 2-4 years of experience in GLP or similar regulated settings, preferably with auditing expertise; strong understanding of regulatory requirements, data integrity, and quality systems; proficiency with electronic data systems and SOPs. Preferred qualifications include knowledge of Part 11 compliance, risk assessments, and vendor evaluations. High-Value: GLP compliance, audit execution, FDA/EPA standards, validation oversight, electronic data systems, and regulatory inspection support. Work setup: Office or laboratory environment; travel is expected for inspections and client interactions; physical activity includes moderate movement and laboratory safety protocols.