Senior Quality Lab Technician

BD Malaysia; Kulim; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading medical company in Kulim is seeking an experienced microbiologist to conduct microbiological analyses and ensure compliance with Good Laboratory Practice standards. The role requires at least 7 years of experience in relevant lab settings, with significant responsibilities such as maintaining lab inventory, documenting test results, and performing sterilization assurance tasks. This position offers a dynamic working environment with direct involvement in laboratory quality engineering and validation activities.

Qualifications

• Minimum 7 years experience in medical device or relevant laboratory.
• Preferred experience in Micro Lab and Sterilization.
• Experience with qualification/validation activities.

Responsibilities

• Conduct all Microbiology Lab testing according to GLP.
• Document and record all test results.
• Order laboratory chemicals and maintain stocks.
• Monitor results from Microbiology Lab.
• Prepare trend data for lab testing.
• Perform Gamma Dose Audit testing.
• Maintain lab equipment.

Skills

Communication in written and oral English and Bahasa Malaysia

Understanding of Biology

Understanding of Chemistry

Understanding of Mathematics

Basic Computer skills – Word, Excel, PowerPoint

Job description

Job Description Summary

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.

Job Description

Responsible for:

• 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.
• 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

Additional Responsibilities

• 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.

Required Skills

Optional Skills

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

Work Shift

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