QA Engineer (Onsite)

Responsibilities

• Quality System Development & Compliance:
• Partner with the QA Manager to establish, optimize, and sustain the site's QMS in alignment with ISO 9001:2015 and other applicable standards. Drive adherence to quality policies and ensure system effectiveness across all operational areas.
• CAPA & Root Cause Analysis:
• Lead end-to-end Corrective and Preventive Action (CAPA) processes - including investigation, root cause analysis (using tools such as Fishbone, 5 Whys), implementation of corrective measures, and verification of effectiveness.
• Audits & Inspections:
• Conduct internal audits, perform supplier audits, support regulatory inspections, and carry out routine on-site quality inspections to ensure compliance and identify improvement opportunities.
• Document Control & Review:
• Review, approve, and maintain controlled documents including SOPs, forms, test plans, and validation protocol/report. Ensure documentation reflects current best practices and regulatory expectations.
• Change & Deviation Management:
• Support and review Engineering Change Orders, Document Change Controls, and Deviations to ensure compliance with SOPs, proper risk assessment, and timely implementation.
• Risk Management:
• Actively participate in risk assessments, Failure Mode and Effects Analysis (FMEA), and implementation of risk mitigation strategies to proactively address potential quality issues.
• Compliance Monitoring:
• Monitor and drive timely closure of CAPAs, completion of training requirements, handling of Non-Conforming Materials (NCMs), and other key QMS metrics to ensure ongoing compliance.
• Data Analysis & Continuous Improvement:
• Analyze quality performance data (e.g., defect rates, audit findings, complaint trends) to identify systemic issues and lead or support continuous improvement projects.
• Product Complaints & NCM Handling:
• Participate in investigations related to customer complaints, product returns, and non-conforming materials - ensuring appropriate containment, correction, and preventive actions are taken.
• Training & Competency Development:
• Develop, deliver, and maintain quality training programs for new hires and existing staff. Ensure personnel competency aligns with QMS requirements.
• Ad Hoc Assignments:
• Perform other duties and special projects as assigned by the QA Manager to support business and quality objectives.
• Qualifications & Requirements:
• Education: Bachelor's degree in Engineering, Biomedical Sciences, Life Sciences, or a related technical field.
• Experience: Minimum 2 years of hands-on experience in quality assurance, preferably within an ISO 9001-certified environment or manufacturing/QA site management role.
• Certifications (Preferred): ISO 9001:2015 Internal Auditor certification is a strong advantage.
• Technical Skills: Proficient in quality tools and methodologies (e.g., CAPA, FMEA, Root Cause Analysis, Statistical Process Control). Familiarity with document control and change management systems.
• Soft Skills: Strong analytical, problem-solving, and communication skills. Highly detail-oriented, self-motivated, and able to thrive in a fast-paced, dynamic environment. Demonstrated ability to manage multiple priorities with minimal supervision.
• Language: Fluency in English (written and spoken) is required. Proficiency in Mandarin Chinese is a distinct advantage for cross-regional collaboration.
• Work Arrangement:
• This is a fully onsite position based in Singapore.
• #GS
• #LI-CT1

Benefits

Additional Information

About GenScript GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy. GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. Position: QA Engineer Report to: QA Manager Job Scope: Support the QA Manager in building, maintaining, and continuously improving the GenScript Singapore Quality Management System (QMS). Ensure full compliance with internal quality standards and regulatory requirements through effective implementation of on-site quality processes, audits, corrective actions, and continuous improvement initiatives.

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