Quality Assurance Specialist II - GCP

📋 Description

• Oversee QA activities to maintain and improve the quality mgmt system per ISO 19011.
• Audit internal processes and support regulatory audits (GCP, GDP, GLP, ICH E6).
• Develop policies/methods to evaluate product quality across materials and operations.
• Lead/participate in clinical studies at SGS Union site and other NA sites.
• Monitor studies in real time; escalate events/non-compliances.
• Ensure study timelines via KPIs; collaborate with cross-functional teams.

🎯 Requirements

• Bachelor’s degree in Biology/Microbiology/Chemistry/Biochemistry/Business Administration or related.
• 3+ years QA/QA process experience; 2+ years QA leadership or seniority role.
• Experience in a GCP environment; GDP/GLP and ICH E6 a strong asset.
• 1+ year Lead Auditor or 3+ years auditing support; 2+ years clinical monitoring.
• Strong knowledge of regulatory systems and Good Clinical Practices.

🎁 Benefits

• Health: Medical, dental, vision, life, EAP.
• Wealth: 401(k) with company match.
• Growth: Online training, development, tuition reimbursement.
• Work-Life Balance: Paid time off and family leave.