Microbiologist III

Boston Scientific; George Town; On-site; MYR 66,960 - 100,440; Full time

Job summary

Boston Scientific in Penang, Malaysia, is seeking a Microbiology Laboratory professional to uphold patient safety and product quality by conducting tests and reviewing data per approved procedures. The role supports internal and external audits and provides guidance to junior lab staff.

The successful candidate will have a Bachelor in a related science field, at least 3 years in a regulated manufacturing lab, and strong knowledge of microbiology and quality systems.

Qualifications

• Bachelor degree in Microbiology, Biotechnology, Chemical, Industrial Science or related field.
• Minimum 3 years of relevant working experience.
• Knowledge of microbiology principles, laboratory operations, and quality systems.
• Experience in a regulated manufacturing environment is a plus.
• Ability to work independently and collaboratively in cross-functional teams.

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).
• Conduct testing according to written procedures.
• Review all data and associated data reports for conformance to specifications.
• Ensure all training is completed per Laboratory Training Program 92048659.
• Ensure notebooks/logbooks/Datasheets are completed and reviewed timely.
• Record all information and raw data on designated forms or logbooks and/or via systems.
• Assist manufacturing/operations/quality personnel in solving quality-related problems.
• Ensure NCE’s, laboratory investigations and Out of Specification results are documented and reported to Laboratory Management.
• Support Internal/External Audits.
• Provide direction to Technician I & II roles.
• Maintain safety awareness in the laboratory.
• Represent the laboratory on cross functional project teams.
• Designee for Senior Microbiologist overseeing day-to-day operation of the Microbiology laboratory.
• Coordinate and/or perform method validations of new products.
• Assist in implementation of new tests, new technology, and improvements to existing tests.
• Perform new equipment qualifications and requalification; write related protocols/reports.
• Documentation control – update documentation to ensure documents are controlled as required.
• Coordinate and train to ensure compliance to mandatory training requirements.
• Communicate concerns about work process regarding environmental impact, health or safety to Sn Microbiologist.
• Assist in writing and updating Procedures, Work Instruction.
• Perform and assist with additional duties as directed by the Senior Microbiologist.

Skills

Microbiological Laboratory Skills

Analytical Skills

Knowledge in Microbiology Medical Dev

Problem Solving Skills

Data review and interpretation

Technical investigation and Troublesh

Communication and cross-functionalColl

cGMP & regulatory knowledge

Test method validation experience

Education

Bachelor of Science in Microbiology, Biotechnology, Chemical, Industrial Science 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).
• Conduct testing according to written procedures.
• Responsible for reviewing all data and associated data reports generated in the laboratory for conformance to specifications.
• Ensure all training is completed as per Laboratory Training Program 92048659.
• 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 personnel in solving quality-related problems.
• Ensures NCE’s, laboratory investigations and Out of Specification results are documented and reported to Laboratory Management.
• Support Internal/External Audits.
• Provide direction to Technician I & II roles.
• Maintain safety awareness in the laboratory.
• Represent the laboratory on cross functional project teams as required.
• Designee for Senior Microbiologist as required, by overseeing the day to day operation of the Microbiology laboratory.
• Co-ordinate and/or perform method validations of new products.
• Assists in the implementation of new tests, new technology, and improvements to existing tests.
• Perform new equipment qualifications and requalification as assigned and write related protocols/reports.
• Documentation control – coordinates and updates documentation within the laboratory to ensure all documents are controlled in line with requirements.
• Coordinate and train to ensure compliance to mandatory training requirements.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Sn Microbiologist.
• Assist in writing and updating Procedures, Work Instruction.
• Perform and assist with additional duties as may be directed by the Senior Microbiologist.

Key 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).
• Conduct testing according to written procedures.
• Responsible for reviewing all data and associated data reports generated in the laboratory for conformance to specifications.
• Ensure all training is completed as per Laboratory Training Program 92048659.
• 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 personnel in solving quality-related problems.
• Ensures NCE’s, laboratory investigations and Out of Specification results are documented and reported to Laboratory Management.
• Support Internal/External Audits.
• Provide direction to Technician I & II roles.
• Maintain safety awareness in the laboratory.
• Represent the laboratory on cross functional project teams as required.
• Designee for Senior Microbiologist as required, by overseeing the day to day operation of the Microbiology laboratory.
• Co-ordinate and/or perform method validations of new products.
• Assists in the implementation of new tests, new technology, and improvements to existing tests.
• Perform new equipment qualifications and requalification as assigned and write related protocols/reports.
• Documentation control – coordinates and updates documentation within the laboratory to ensure all documents are controlled in line with requirements.
• Coordinate and train to ensure compliance to mandatory training requirements.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Sn Microbiologist.
• Assist in writing and updating Procedures, Work Instruction.
• Perform and assist with additional duties as may be directed by the Senior Microbiologist.

Requirements

• Bachelor of Science in Microbiology, Biotechnology, Chemical, Industrial Science or any related field.
• Minimum 3 years of relevant working experience.
• Knowledge of microbiology principles, laboratory operations, and quality systems.
• Experience in a regulated manufacturing environment will be an added advantage.
• Ability to work independently and collaboratively in a cross-functional environment.

Required Skills

• Microbiological Laboratory Skills.
• Analytical Skills.
• Knowledge in Microbiology Medical Device Testing.
• Problem Solving Skills and Analytical Thinking.
• Data review and interpretation.
• Technical investigation and troubleshooting.
• Good communication and cross-functional collaboration skills.
• Understanding of cGMP, regulatory requirements, environmental control, and laboratory quality systems.
• Experience in test method validation and laboratory investigations will be an added advantage.

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.