Laboratory Technician II

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

• Demonstrate a primary commitment to patient safety and product quality.


• Understand and comply with all the regulations governing the quality systems (including ISO 17025 for accredited laboratory) and ensure all training is completed as per Laboratory Training Program.


• Delivery of key Quality and Performance Objectives.


• Conduct testing according to written procedures - Environmental Control testing (including water/air & surface microbial/air particulate) of controlled areas within the plant, Endotoxin and Bioburden testing (routine/ batch release/ validation) for Microbiology test support; Raw material, in-process and finished product testing for Analytical test support.


• Collect, compile and analyse data and prepare laboratory reports.


• Ensures all notebooks/logbooks/Datasheets are completed and reviewed in a timely manner. Records all information and raw data only on designated forms or logbooks and/or via appropriate systems.


• Assist manufacturing/operations/quality in solving quality-related problems.


• Ensures NCE’s, laboratory investigations and out of specification results are documented and reported to Laboratory Management.


• Ensure equipment standards and other materials are approved/released prior to use.


• Performs cleaning, preventative maintenance, verification of instruments and equipment where required.


• Perform new equipment qualifications and requalifications as assigned and write related protocols/reports.


• Support Internal/External Audits.


• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.


• To build quality into all aspects of work by maintaining compliance to all quality requirements.


• Perform and assist with additional duties as may be directed by the Supervisor.

Requirements

• Diploma or Bachelor’s Degree in Analytical Chemistry, Chemistry, Pharmaceutical Science, Chemical Engineering, Biotechnology, Materials Science, or other related science disciplines.


• 2–5 years of relevant laboratory experience in an analytical or quality control laboratory.


• Experience in a regulated industry preferred (Medical Devices, Pharmaceutical, Biotechnology, or Chemical Manufacturing).


• Experience with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) is highly desirable.


• Experience performing routine laboratory testing.

Required Skills

• Hands-on experience with analytical instrumentation such as HPLC/GC, FTIR, Dissolution Testing, pH Meter, and Analytical/Micro Balance.


• Sample preparation and handling techniques.


• Calibration, verification, and routine maintenance of laboratory equipment.


• Ability to troubleshoot minor instrument issues.


• Knowledge of method execution according to validated procedures.


• Understanding of GMP, GLP, Good Documentation Practices (GDP), and Data Integrity (ALCOA+ Principles).


• Knowledge of ISO 13485 and FDA 21 CFR Part 820 / Quality Management System requirements is preferred.


• Knowledge of laboratory safety and chemical handling.


• Strong attention to detail and adherence to quality requirements.


• Good communication and teamwork skills.

About Us

As a global medical technology leader for more than 45 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.