Analytical QC Technician — GMP/ISO 17025

Boston Scientific; George Town; On-site; MYR 72,000 - 108,000; Full time

Job summary

Boston Scientific Malaysia is seeking a diligent analytical chemistry professional to join our quality and laboratory team. You will ensure compliance with GMP/GLP, ISO 13485, and ISO 17025 requirements while performing routine analytical testing and contributing to product quality and patient safety.

In this role, you will handle HPLC/GC and other instrumentation, document results, support internal and external audits, and help drive continuous improvement within a regulated laboratory

Qualifications

• Diploma or Bachelor's degree in analytical sciences or related field.
• 2–5 years of relevant lab experience in analytical or quality control labs.
• Experience in regulated industries (Medical Devices/Pharma/Biotech) preferred.
• Experience with GMP and GLP is highly desirable.
• Experience performing routine laboratory testing.

Responsibilities

• Demonstrate a primary commitment to patient safety and product quality.
• Understand and comply with all quality system regulations including ISO 17025.
• Deliver key Quality and Performance Objectives.
• Conduct testing according to procedures for Environmental Control and microbiology support.
• Collect, compile, analyse data and prepare laboratory reports.
• Maintain notebooks/logbooks and data records accurately.
• Assist manufacturing/operations/quality in solving quality issues.
• Document NCEs, investigations and out-of-spec results.
• Ensure equipment standards and materials are approved before use.
• Perform cleaning, preventive maintenance, and verification of instruments.
• Carry out new equipment qualifications and write related protocols/reports.
• Support internal/external audits.
• Communicate safety/environment concerns to the Manager.
• Build quality into all work and maintain compliance with quality requirements.
• Perform and assist with additional duties as directed by the Supervisor.

Skills

HPLC/GC

FTIR

Dissolution Testing

pH Meter

Analytical/Micro Balance

Sample preparation

Calibration & maintenance

Troubleshooting

Validated procedures

GMP/GLP/Data Integrity

ISO 13485 / FDA 21 CFR Part 820

Laboratory safety

Attention to detail

Communication & teamwork

Education

Diploma or Bachelor’s degree in Analytical Chemistry or related field

Job description

Boston Scientific Malaysia is seeking a diligent analytical chemistry professional to join our quality and laboratory team. You will ensure compliance with GMP/GLP, ISO 13485, and ISO 17025 requirements while performing routine analytical testing and contributing to product quality and patient safety.

In this role, you will handle HPLC/GC and other instrumentation, document results, support internal and external audits, and help drive continuous improvement within a regulated laboratory