### 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.
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