Clinical Laboratory Quality Assurance Specialist

Yikon Genomics (Malaysia) Sdn. Bhd; Kuala Lumpur; Sur place; MYR 60 000 - 80 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Technical writing

Communication skills

Regulatory knowledge

Auditor certification

Formation

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

Outils

Microsoft Office

Description du poste

Clinical Laboratory Quality Assurance Specialist

Quality Management System Documentation:

Responsible for and/or assist with the daily management of quality management system documents to ensure that all documents currently in use are up to date and valid. Coordinate the preparation, review and approval, training, distribution, filing, revision, retrieval, destruction, borrowing, and periodic review of documents. Track and maintain the current validity of external technical documents. Organize document controllers from different laboratory sections to carry out internal document management activities.

Quality Management System Training:

Responsible for providing training to laboratory employees on relevant quality management system requirements.

Routine Quality Supervision and Inspection:

Conduct routine supervision and inspections covering testing processes, relevant records, equipment, personnel, reagents, environmental conditions, and other related areas.

Nonconformity Management and Corrective Actions:

Assist in the identification and management of internal and external nonconformities, assign relevant departments to conduct investigations and root-cause analyses, and follow up on corrective and improvement actions, including their tracking, statistical analysis, and reporting.

Internal and External Quality Control:

Responsible for supervising and following up on internal quality control (IQC) and external quality assessment/proficiency testing (EQA/PT), as well as maintaining and archiving relevant records.

Internal Audit and Management Review:

Assist the Quality Manager/Quality Officer in conducting internal audits, management reviews, and other quality management system activities.

Other Responsibilities:

Perform other duties and responsibilities assigned to this position as stipulated in the company's quality management system documentation.

Other Assigned Tasks:

Complete other tasks assigned by management.

Qualifications

Education

Major in Biology, Pharmaceutical Sciences, Medical Laboratory Science, or a related field.

College diploma or above.

Work Experience

At least 1 year of relevant work experience in a medical institution, preferably in document control, quality systems, or Quality Assurance (QA). Experience in an NGS-based clinical/medical testing laboratory is preferred.

Strong technical writing and communication skills, with proficiency in Microsoft Office.

Familiarity with relevant laws, regulations, and standards applicable to medical institutions in Malaysia, as well as ISO 15189 or CAP requirements.

Candidates holding an ISO 15189 or CAP Internal Auditor certificate are preferred.

Candidates with extensive hands-on/front-line quality management experience are preferred. - what title is this call