Senior Lab Technician — GMP/GLP Analytics & QC

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.

Penang

On-site

MYR 67,000 - 100,000

Full time

14 days+

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Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. offers opportunities in a regulated analytical laboratory environment.

The role focuses on environmental control testing, endotoxin and bioburden analyses, and routine analytical testing to support quality systems. Qualified candidates bring 2–5 years of lab experience, GMP/GLP understanding, and hands-on skills with HPLC/GC, FTIR, and dissolution testing.

Qualifications

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.

Responsibilities

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 of controlled areas within the plant, Endotoxin and Bioburden testing 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.
Ensure notebooks/logbooks/Datasheets are completed and reviewed in a timely manner.
Assist manufacturing/operations/quality in solving quality-related problems.
Ensure 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.