Quality Assurance Specialist

Remote based Mandarin Speaking Quality Assurance Specialist role - Must be able to travel occasionally to China.

Job Description:

We are seeking a detail-oriented and proactive Mandarin-speaking Quality Assurance (QA) professional to join our team, a leading CGT CDMO. In this role, you will ensure that all manufacturing processes comply with Good Manufacturing Practices (GMP) and regulatory standards. You will work closely with cross-functional teams to maintain quality and safety standards throughout the production cycle.

Responsibilities:

• Conduct regular GMP audits and inspections to ensure compliance with internal and regulatory quality standards.
• Review and approve batch records, production documentation, and quality reports.
• Coordinate with production teams to address any non-compliance issues or discrepancies.
• Assist in the preparation of regulatory submissions and audits.
• Communicate effectively in Mandarin with local teams and stakeholders.
• Support continuous improvement initiatives to optimize quality assurance processes.

Qualifications:

• Fluent in Mandarin (written and spoken).
• Experience in Quality Assurance within a GMP-regulated environment.
• Strong understanding of regulatory requirements in manufacturing.
• Excellent attention to detail and problem-solving skills.