QA Engineer

Responsibilities

• Build, maintain, and improve the Singapore Quality Management System under the QA Manager
• Ensure compliance with ISO 9001:2015 and regulatory requirements across site operations
• Lead CAPA processes including investigation, root cause analysis, and effectiveness verification
• Conduct internal and supplier audits and support regulatory inspections
• Review and maintain controlled documents such as SOPs, test plans, and validation protocols
• Manage change orders, document change controls, and deviations per SOPs
• Participate in risk assessments and FMEA to proactively address quality issues
• Monitor QMS metrics, analyze quality data, and drive continuous improvement
• Investigate product complaints and non-conforming materials with containment and corrective actions
• Develop and deliver quality training to ensure staff competency

Requirements

• Bachelor's degree in Engineering, Biomedical Sciences, Life Sciences, or related technical field
• Minimum 2 years hands-on QA experience, preferably in an ISO 9001-certified environment
• ISO 9001:2015 Internal Auditor certification preferred
• Proficient in CAPA, FMEA, Root Cause Analysis, and Statistical Process Control
• Strong analytical, problem-solving, and communication skills
• Fluency in English required; Mandarin Chinese proficiency preferred

About the Company

GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with essential building blocks for treatments and products. Founded in 2002 in New Jersey, GenScript serves more than 200,000 customers across over 100 countries with approximately 6,165 employees.