Quality Assurance Auditor II

Role: Quality Assurance Auditor in a GLP-regulated environment, focusing on PK, ADA, biomarkers, and Sample Analysis within biopharma. Objectives: ensure compliance with FDA, EPA, and international GLP standards through facility and process audits, and maintain data integrity. Responsibilities: conduct audits of studies and facilities, review protocols and data, prepare reports, and support regulatory inspections. Qualifications: B.S. in chemistry, life sciences, or related field; 2-4 years' experience in regulated labs, with knowledge of GLP, PK, ADA, biomarkers, and ICH M10 guidelines. Skills: strong communication, organization, understanding of lab procedures, government regulations, and proficiency with quality management software. High-Value: role involves GLP compliance, regulatory audit support, and quality systems management in preclinical or early clinical phases. Collaboration: work with study teams, regulatory bodies, and vendors; may serve as a resource on regulatory topics. WorkSetup: primarily office/lab-based, with travel expected for audits and inspections. Physical and working conditions include moderate physical activity, use of PPE, and exposure to laboratory hazards.