Quality Lab Technician II — GMP/GLP Focus

Boston Scientific Corporation; Penang; On-site; MYR 45,000 - 78,000; Full time

Job summary

Boston Scientific Corporation in Penang, Malaysia is recruiting for a laboratory quality role. The position focuses on analytical testing, GMP/GLP compliance and data integrity within a regulated environment.

The candidate will perform environmental control testing, endotoxin and bioburden analyses, and raw material/ in-process/ finished product testing, compiling data and maintaining proper documentation while supporting audits and training programs.

Qualifications

• Diploma or Bachelor’s degree in analytical science or related field.
• 2–5 years of relevant laboratory experience in analytical or quality control laboratory.
• Experience in regulated industry preferred (Medical Devices, Pharmaceutical, Biotechnology, or Chemical Manufacturing).
• 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 regulations governing quality systems (including ISO 17025) and ensure Laboratory Training Program completion.
• Delivery of key Quality and Performance Objectives.
• Conduct testing according to written procedures: Environmental Control testing, Endotoxin and Bioburden testing, and Raw material/ in-process/ finished product testing for Analytical support.
• Collect, compile and analyse data and prepare laboratory reports.
• Maintain notebooks/logbooks/Datasheets and record data on designated forms or systems.
• Assist manufacturing/operations/quality in solving quality-related problems.
• Ensure NCE investigations and out-of-spec results are documented and reported to Laboratory Management.
• Ensure equipment standards and materials are approved/released prior to use.
• Perform cleaning, preventative maintenance, verification of instruments and equipment.
• Perform new equipment qualifications and requalifications and write related protocols/reports.
• Support Internal/External Audits.
• Communicate concerns about work process to the Manager.
• Build quality into all work by complying with quality requirements.
• Perform additional duties as directed by the Supervisor.

Skills

HPLC/GC

FTIR

Dissolution Testing

pH Meter

Analytical/Micro Balance

Sample Preparation

Calibration

GMP/GLP Knowledge

GDP & Data Integrity

ISO13485 Knowledge

FDA 21 CFR Part 820 Knowledge

Laboratory Safety

Attention to Detail

Communication

Teamwork

Education

Bachelor's/Diploma in Analytical Chemistry or related field

Job description

Boston Scientific Corporation in Penang, Malaysia is recruiting for a laboratory quality role. The position focuses on analytical testing, GMP/GLP compliance and data integrity within a regulated environment.

The candidate will perform environmental control testing, endotoxin and bioburden analyses, and raw material/ in-process/ finished product testing, compiling data and maintaining proper documentation while supporting audits and training programs.