Microbiologist II

<div><h3>Key Responsibilities</h3><ul><li>Demonstrate a primary commitment to patient safety and product quality.</li><li>Understand and comply with all the regulations governing the quality systems (including ISO 17025).</li><li>Conduct testing according to written procedures.</li><li>Responsible for reviewing all data and associated data reports generated in the laboratory for conformance to specifications.</li><li>Ensure all training is completed as per Laboratory Training Program 92048659.</li><li>Ensures all notebooks/logbooks/Datasheets are completed and reviewed in a timely manner.</li><li>Records all information and raw data only on designated forms or logbooks and/or via appropriate systems.</li><li>Assist manufacturing/operations/quality personnel in solving quality-related problems.</li><li>Ensures NCE’s, laboratory investigations and Out of Specification results are documented and reported to Laboratory Management.</li><li>Support Internal/External Audits.</li><li>Provide direction to Technician I & II roles.</li><li>Maintain safety awareness in the laboratory.</li><li>Represent the laboratory on cross functional project teams as required.</li><li>Designee for Senior Microbiologist as required, by overseeing the day to day operation of the Microbiology laboratory.</li><li>Co-ordinate and/or perform method validations of new products.</li><li>Assists in the implementation of new tests, new technology, and improvements to existing tests.</li><li>Perform new equipment qualifications and requalification as assigned and write related protocols/reports.</li><li>Documentation control – coordinates and updates documentation within the laboratory to ensure all documents are controlled in line with requirements.</li><li>Coordinate and train to ensure compliance to mandatory training requirements.</li><li>Communicates any concerns about work process regarding environmental impact, health or safety issues to their Sn Microbiologist.</li><li>Assist in writing and updating Procedures, Work Instruction.</li><li>Perform and assist with additional duties as may be directed by the Senior Microbiologist.</li></ul><h3>Requirements</h3><ul><li>Bachelor of Science in Microbiology, Biotechnology, Chemical, Industrial Science or any related field.</li><li>Minimum 3 years of relevant working experience.</li><li>Knowledge of microbiology principles, laboratory operations, and quality systems.</li><li>Experience in a regulated manufacturing environment will be an added advantage.</li><li>Ability to work independently and collaboratively in a cross-functional environment.</li></ul><h3>Required Skills</h3><ul><li>Microbiological Laboratory Skills.</li><li>Analytical Skills.</li><li>Knowledge in Microbiology Medical Device Testing.</li><li>Problem Solving Skills and Analytical Thinking.</li><li>Data review and interpretation.</li><li>Technical investigation and troubleshooting.</li><li>Good communication and cross-functional collaboration skills.</li><li>Understanding of cGMP, regulatory requirements, environmental control, and laboratory quality systems.</li><li>Experience in test method validation and laboratory investigations will be an added advantage.</li></ul></div><p>About Us</p><p>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.</p>