Clinical Lab QA & Compliance Specialist

Yikon Genomics (Malaysia) Sdn. Bhd; Kuala Lumpur; On-site; MYR 60,000 - 80,000; Full time

Job summary

Yikon Genomics (Malaysia) Sdn. Bhd is seeking a Clinical Laboratory Quality Assurance Specialist to oversee the quality management system documentation, coordinate reviews and approvals, and ensure current records are maintained across the lab.

The role requires strong technical writing and communication skills, familiarity with Malaysia regulations and ISO 15189 or CAP standards, and at least 1 year of QA experience in a medical setting.

Qualifications

• Education: College diploma or above in Biology, Pharmaceutical Sciences, Medical Laboratory Science, or related field.
• Experience: At least 1 year in a medical institution, preferably in document control, quality systems, or QA; NGS lab experience preferred.
• Skills: Strong technical writing and communication; proficiency in Microsoft Office.
• Regulatory: Familiarity with Malaysia laws, regulations, and standards; ISO 15189 or CAP Internal Auditor certificates preferred.

Responsibilities

• Manage QMS documentation; ensure records are up to date and accessible.
• Provide training on quality management system requirements to lab staff.
• Conduct routine supervision and inspections of testing processes, equipment, records, and environmental conditions.
• Assist in nonconformity identification, root-cause analysis, and corrective actions with tracking and reporting.
• Oversee IQC and EQA/PT programs and maintain related records.
• Assist in internal audits, management reviews, and other QMS activities.
• Complete other tasks as assigned by management.

Skills

Technical writing

Communication skills

Regulatory knowledge

Auditor certification

Education

Biology / Pharmaceutical Sciences / Medical Laboratory Science (college diploma or above)

Tools

Microsoft Office

Job description

Yikon Genomics (Malaysia) Sdn. Bhd is seeking a Clinical Laboratory Quality Assurance Specialist to oversee the quality management system documentation, coordinate reviews and approvals, and ensure current records are maintained across the lab.

The role requires strong technical writing and communication skills, familiarity with Malaysia regulations and ISO 15189 or CAP standards, and at least 1 year of QA experience in a medical setting.