Quality Assurance Specialist

Key Responsibilities

• Support daily QA operations related to document control, change control, training, and CAPA management.
• Review and approve production records, quality documentation, and deviations in compliance with internal procedures.
• Assist with internal and external audits by preparing records, reports, and responses to findings.
• Maintain and update Standard Operating Procedures (SOPs) and ensure proper document archiving and version control.
• Coordinate and track employee training to ensure compliance with quality and regulatory requirements.
• Support nonconformance and complaint investigations, assisting in root cause analysis and corrective actions.
• Collaborate with QC, Production, and Regulatory teams to ensure cross- functional compliance and communication.
• Monitor quality metrics and support continuous improvement initiatives within the Quality Management System.
• Communicate effectively in both English and Korean across teams and departments.

Qualifications