Microbiologist III

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.