Quality Assurance Specialist II

📋 Description

• Oversee quality management and audits per ISO 19011 and regulatory standards
• Support regulatory audits and maintain accreditation readiness
• Develop policies to improve product quality and operations
• Lead studies at SGS Union site and assist other North America sites
• Monitor clinical study documentation from start to finish
• Ensure timely KPIs and cross-functional collaboration for study timelines

🎯 Requirements

• Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, or related fields
• 3+ years QA experience; 2+ years QA/Operational Leadership
• Working knowledge of GCP, GDP, GLP and ICH E6 standards
• 1+ year Lead Auditor or 3+ years auditing support experience
• 2+ years clinical monitoring experience
• Excellent understanding of Good Clinical Practices and regulatory systems

🎁 Benefits

• Health, dental, vision, life insurance
• 401(k) with company match
• Online training, tuition reimbursement
• Paid time off and family leave