Lab Quality Management Specialist
3 weeks ago
Technical Operations & Laboratory Management
- Support the management team in overseeing the planning, development, and execution of laboratory operations.
- Develop and implement policies and Standard Operating Procedures (SOPs) to ensure operational efficiency.
- Ensure laboratory instruments and equipment are properly validated, calibrated, and maintained in compliance with College of American Pathologists (CAP), ISO 15189, and MOH regulatory standards.
- Oversee the development, validation, and implementation of new lab tests, ensuring alignment with other relevant guidelines.
- Continuously improve existing laboratory processes and methods, providing training and knowledge transfer to technical staff.
- Evaluate laboratory infrastructure and equipment, making recommendations for enhancements to improve efficiency and capacity.
- Ensure laboratory safety and compliance with biosafety regulations and industry-standard health and safety protocols.
- Assist the technical team in the development, validation and implementation of novel scientific and clinical tests.
- Ensure the handling of clinical test specimens are in accordance to protocol
- Perform experiments on incoming projects to the laboratory and submit samples for downstream processing
Quality Assurance & Compliance
- Develop, implement, and maintain a comprehensive Laboratory Quality Management System (QMS).
- Lead internal and external audits, ensuring compliance with CAP, ISO 15189, MOH, and other accrediting bodies.
- Act as the Management Representative for quality certifications, coordinating audits and enforcing regulatory requirements.
- Establish and monitor Quality Control (QC) and Quality Assurance (QA) programs, ensuring continuous quality improvement.
- Champion the use of statistical and quality management tools to enhance laboratory performance and accuracy.
- Conduct inter-departmental quality audits, assess client quality requirements, and implement corrective and preventive actions (CAPA).
- Drive continuous improvement initiatives to optimize test turnaround time (TAT) and operational efficiency.
Risk Management & Resource Planning
- Develop and implement risk management strategies to ensure laboratory compliance with regulatory and accreditation requirements.
- Oversee procurement, supply chain, and logistics for laboratory materials, ensuring cost efficiency and operational continuity.
- Ensure the laboratory is audit-ready at all times for regulatory inspections, licensing renewals, and accreditation assessments.
Requirements
- Master's degree or PHD in life sciences or biotechnology disciplines.
- Minimum 5 years of experience in a clinical diagnostic laboratory with a focus on molecular or microbiology disciplines.
- At least 3 years of experience in quality assurance/management.
- Hands-on experience in a CAP/ISO 15189-accredited medical laboratory setting.
- Strong background in laboratory safety practices, particularly BSL-2+ environments.
- Proven ability to lead teams, implement quality management methods, and oversee laboratory workflows.
- Experience in auditing, compliance, and risk management in a laboratory setting.
- In-depth knowledge of industry standards (CAP, ISO 15189, HSCA, MOH).
- Strong technical expertise in molecular diagnostic techniques and laboratory best practices.
- Excellent decision-making, problem-solving, and project management skills.
- Ability to thrive in a fast-paced, high-throughput laboratory environment.
- Effective communication, leadership, and team collaboration skills.
Management Skills
Quality Control
Quality Management
Quality Assurance
Quality Improvement
ISO
Microbiology
Risk Management
Compliance
Regulatory Requirements
Laboratory
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