Boston Scientific Laboratory Technician II 

Malaysia, Penang 

955657518

Purpose Statement:

To perform routine analytical or Microbiology testing as assigned and to accurately document tests results. They are responsible for ensuring that all testing is carried out in line with all quality system and regulatory requirements.

Job 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 (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.

Job Requirements:

• Candidates require process at least Diploma or Degree in Chemistry, Analytical Chemistry, Applied Science or Life Science.
• Education/ background in Analytical Lab set-up, Analytical equipment troubleshooting and Chemical Analysis.
• Skill required: FTIR, HPLC, GCMS, GCFID Analytical Analysis.
• Additional knowledge: GMP, GLP, ISO13485