Laboratory QA Engineer

Role and Responsibilities

The Laboratory QA Engineer is responsible for maintaining and monitoring the effectiveness of the Laboratory Quality Management System in accordance with ISO/IEC 17025 and internal requirements. The role manages document control, supports internal audits and management reviews, monitors nonconformities and corrective actions, oversees quality assurance activities, supplier evaluation, equipment/reference standard controls, and compliance of laboratory facilities and records. The QA Engineer also verifies that laboratory activities are performed consistently with approved procedures and supports continual improvement of the laboratory management system

Key Responsibilities :

1. Document Control As the Laboratory Document Controller, the responsible person shall:

• Manage the issuance, revision, approval, distribution, and withdrawal of documents within the Laboratory Quality Management System.
• Control changes to Laboratory Quality Management System documents and ensure that only the current approved versions are available at the points of use.
• Coordinate the communication and implementation of newly issued or revised documents to all relevant laboratory personnel.
• Follow up on Document Change Requests (DCRs) that have been reviewed and approved by the Laboratory Manager.
• Support the Laboratory Manager in coordinating periodic document reviews and ad hoc reviews, as required.
• Maintain controlled laboratory documents and records and ensure their integrity, security, confidentiality, accessibility, retention, and appropriate disposal in accordance with established requirements.

2.Quality Management System Implementation and Monitoring

• Support the Laboratory Manager in preparing and maintaining the schedule of Laboratory Quality Management System activities, including internal audits, management reviews, document reviews, quality system training, and other relevant quality activities.
• Verify the implementation and effectiveness of the Laboratory Quality Management System, including compliance with laboratory procedures, work instructions, methods, forms, and record-keeping requirements.
• Identify and report deviations, nonconformities, and inconsistencies in the implementation of the Laboratory Quality Management System to the Laboratory Manager.
• Monitor compliance with applicable Laboratory Quality Management System requirements and support continual improvement of the system.

3. Nonconformity, Corrective Action, and Audit Follow-up

• Support the Laboratory Manager in coordinating the investigation and follow-up of nonconformities arising from customer complaints, internal audits, external audits, proficiency testing, quality control activities, or other identified sources.
• Monitor the implementation of corrective actions and verify their effectiveness after completion.
• Monitor actions taken to address identified risks and opportunities related to laboratory technical activities and the Quality Management System.
• Coordinate or arrange additional internal audits or follow-up assessments when necessary to verify the effectiveness of corrective actions.

4. Management Review

• Support the Laboratory Manager in preparing and coordinating periodic Laboratory Management Review meetings.
• Compile and present relevant information regarding the performance and effectiveness of the Laboratory Quality Management System, including, as applicable: results of internal and external audits, status of corrective actions, customer complaints and feedback, proficiency testing and interlaboratory comparison results, internal quality control results, changes affecting laboratory activities, risks and opportunities, supplier performance, resource requirements, opportunities for improvement
• Monitor and follow up on actions agreed upon during Management Review meetings.

5. Equipment and Reference Standards Control

• Ensure that each item of laboratory equipment, measuring instrument, and reference standard is assigned a unique identification and appropriately recorded in the laboratory equipment management system.
• Monitor the calibration, verification, maintenance, and status of equipment and reference standards in accordance with established laboratory requirements.
• Ensure that reference standards and reference materials used by the Laboratory have appropriate metrological traceability, where applicable, to the International System of Units (SI) or to certified reference materials.

6. External Providers and Supplier Evaluation

• Coordinate the qualification, monitoring, and periodic performance evaluation of external providers supplying products and services that may affect laboratory activities.
• These may include suppliers of: chemicals and reagents, gases, glassware and laboratory consumables, requipment and spare parts, reference materials, calibration services, maintenance services, other externally provided laboratory services
• Maintain appropriate supplier evaluation records and communicate significant supplier performance issues to the Laboratory Manager.

7. Laboratory Facilities and Environmental Conditions

• Monitor laboratory facilities and environmental conditions to ensure their suitability for laboratory activities and compliance with the requirements of applicable test methods.
• Monitor relevant environmental parameters, where required, such as temperature, relative humidity, cleanliness, vibration, contamination, or other conditions that may affect the validity of test results.
• Control and monitor access to laboratory areas to prevent unauthorized access, contamination, interference, or other conditions that could adversely affect laboratory activities.

8. Metrological Traceability and Reference Materials

• Ensure that reference materials and reference standards are appropriately identified, controlled, stored, handled, and monitored throughout their period of use.
• Ensure, where technically applicable, the metrological traceability of measurement results to SI units through appropriate calibration chains or certified reference materials.
• Monitor the validity, expiry dates, certificates, and storage requirements of reference materials and reference standards.

9. Quality Assurance of Test Results

• Coordinate and monitor internal quality control activities to ensure the ongoing validity of laboratory test results.
• Ensure the appropriate use of reference materials, secondary reference materials, control samples, check standards, replicate testing, or other suitable quality control techniques.
• Review and evaluate quality control data using appropriate statistical techniques, where applicable.
• Monitor trends in quality control results and initiate appropriate investigation when results fall outside established acceptance criteria or indicate an adverse trend.
• Report significant quality control issues to the Laboratory Manager and support the investigation and implementation of appropriate corrective actions.

GENERAL REQUIREMENTS

Education and Competencies

• Education min. S1 Science / Pharmacy, or S1 engineering equivalent education that has at least 5 years of experience as a laboratory engineer and or laboratory QA.
• Able to operate and have excellent knowledge of various laboratory instrumentation
• Have a good analytical mind and problem-solving
• Able to operate a computer well
• Have good English (active and passive)
• Have good communication skills
• Good knowledge and practice of ISO17025 and Good Laboratory Practice
• Good knowledge and practice of ISO9001 and ISO 14001

Personal Attributes

• Having strong leadership skills
• Able to work at all levels of the organization
• Self-starter , has high initiative to make performance improvements
• Able to work both independently and in a team
• Has high precision
• Has good time management

Physical and Psychological Requirements

• Good health condition (based on medical examination results).
• Must be able to accurately distinguish color-coded materials, indicators, or quality standards as required for the role.
• Good self-confidence.
• Details.