Quality Assurance Specialist II

Responsibilities

• Ensure compliance with quality management systems for clinical trial studies on human subjects
• Adhere to and implement the SGS Cosmetics and Hygiene Quality Manual
• Participate in clinical study monitoring and internal/external audits
• Conduct real-time reviews of clinical study documentation and escalate non-compliances
• Monitor key performance indicators (KPIs) to ensure study completion timelines are met
• Develop cross-training course lists for North America QA support

Requirements

• Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry, Business Administration, or Quality Assurance
• 3+ years of experience as a Quality Assurance Professional
• 2+ years of experience in a Quality Assurance or Operational Leadership role
• Working knowledge of GCP, GDP, GLP, and ICH E6 standards
• 1+ year of experience as a Lead Auditor or 3+ years supporting an auditing team
• 2+ years of experience in clinical monitoring
• Strong knowledge of ISO, FDA, and ICH regulatory systems

Benefits

• Medical, dental, and vision insurance
• Life insurance and employee assistance programs
• 401(k) with company match and immediate vesting
• Professional growth through online training and tuition reimbursement
• Paid time off and family leave

About the Company

SGS is the world's leading testing, inspection, and certification company, recognized as the global benchmark for sustainability, quality, and integrity.