Quality Assurance Specialist II - GCP

📋 Description

• Ensure compliance with the requirements of a quality management system to demonstrate SGS’s ability
• Ensure SGS Cosmetics and Hygiene Quality Manual is always adhered to for activities performed at
• Actively participates in clinical study monitoring at SGS Union site along with active
• Conducts routine oversight of ongoing clinical studies by conducting real time reviews of clinical
• Ensure Study completion timelines are met by implementing and monitoring key performance indicators
• Self-motivated and agile to assess, organize competing priorities and execute tasks with utmost

🎯 Requirements

• Bachelor’s degree in one or more of the following areas: Biology or Microbiology, Chemistry or
• 3+ years of experience as a Quality Assurance Professional and 2+ years of experience in a Quality
• Must have experience working in a GCP environment. GDP, GLP and ICH E6 standards are a strong asset
• 1+ year of experience as a Lead Auditor, or 3+ years as support on an auditing team Required
• 2+ year of experience in clinical monitoring
• Excellent working knowledge of Good Clinical Practices and regulatory systems [ISO, FDA, ICH]

🎁 Benefits

• Medical, dental and vision insurance, life insurance, employee assistance programs.
• 401(k) with company match (immediate vesting upon enrollment).
• Professional Growth: Online training courses, virtual and classroom development experiences
• Work-Life Balance: Paid-time off and family leave