Senior Quality Lab Technician

BD Nogales Norte; Kulim; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading medical device company in Kulim, Malaysia, is seeking an experienced microbiologist to conduct laboratory testing and ensure compliance with Good Laboratory Practices. Candidates should have at least 7 years of experience in a relevant laboratory setting. Responsibilities include performing microbiological tests, managing lab inventory, and supporting quality validation activities. Strong communication skills in English and Bahasa Malaysia are essential. This position requires a systematic approach and attention to detail.

Qualifications

• Minimum 7 years of experience in a laboratory, preferably in medical devices.
• Experience with sterilization and microbiology lab operations.
• Ability to maintain laboratory equipment and ensure compliance with GLP.

Responsibilities

• Conduct microbiological tests according to GLP.
• Document all test results accurately.
• Manage laboratory inventory and order supplies.
• Support quality engineer in validation activities.

Skills

Communication in English and Bahasa Malaysia

Understanding of Biology

Understanding of Chemistry

Systematic and analytical skills

Basic computer skills (Word, Excel, PowerPoint)

Education

Experience in medical device or relevant industry laboratory (7+ years)

Micro Lab and Sterilization experience

Experience with qualification/validation activities

Job description

Overview

Perform a comprehensive range of microbiological analyses, ensuring all laboratory equipment, chemicals, and glassware are maintained according to Good Laboratory Practice (GLP) standards and sterilization protocols. Execute all necessary microbiological tests and coordinate the maintenance and calibration of laboratory equipment. Support Lab Quality Engineer in validation activities. Additionally, oversee and manage lab inventory and maintenance tasks.

Responsibilities

• All Microbiology Lab testing and conduct them according to GLP.
• Proper documentation and recording of all test results.
• Stocking and ordering of laboratory chemicals, media and other supplies.
• Monitoring all results produced by Microbiology Lab.
• Preparing trend micro lab testing data
• Performing Gamma Dose Audit testing.
• Maintenance of lab equipment.

Comply with all local, state, federal, and BD Safety regulations, policies, and procedures including RCRA Hazardous waste regulations. Other duties as assigned.

Education And Experience

Working experience of minimum 7 years in the medical device or relevant industry laboratory. Preferable with Micro Lab and Sterilization experience. Experience with qualification/validation activities.

Knowledge And Skills

• Must be able to communicate in written and oral English and Bahasa Malaysia.
• Good understanding of Biology, Chemistry and Mathematics.
• Must be able to follow standard laboratory procedures.
• Must be systematic and analytical.
• Basic Computer skills – Word, excel, PowerPoint applications.

Physical Demands

• Preparing sterilization certification release
• Preparing Quarantine shipment product - Exhibit A and verifying Quarantine Certificate - Exhibit B and Quarantine product release - Exhibit C for shipment.
• Preparation of SOP’s, limit calculation, validation protocols, preparation and execution of process validation/qualification.

Specific Laboratory Testing

• Sterility test
• Maintenance of stock culture
• Environmental monitoring on air and work surface and water analysis
• Product bioburden
• Microorganism identification
• Bacteriostasis and fungi stasis
• Bioburden recovery test

To assist Lab Quality Engineer in dummy/PCD preparation during EO and Gamma sterilization validation. To assist Microbiologist in starting up new test methods and in writing test methods.

Ensure good housekeeping and 5S practice in Microbiology Lab.

To assist Lab Quality Engineer in OOS investigation of testing failures. Ensure adherence to Environmental, Safety and Health policies.

Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.

Additional Information

Required Skills

Optional Skills

Work Location and Shifts

Primary Work Location: MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

Work Shift: MY3 Normal 8a-4.45p Group 26 (Malaysia)