Laboratory Technician II

Job description

### 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 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. ### ### Requirements - Diploma or Bachelor’s Degree in Analytical Chemistry, Chemistry, Pharmaceutical Science, Chemical Engineering, Biotechnology, Materials Science, or other related science disciplines. - 2–5 years of relevant laboratory experience in an analytical or quality control laboratory. - Experience in a regulated industry preferred (Medical Devices, Pharmaceutical, Biotechnology, or Chemical Manufacturing). - Experience with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) is highly desirable. - Experience performing routine laboratory testing. ### ### Required Skills - Hands-on experience with analytical instrumentation such as HPLC/GC, FTIR, Dissolution Testing, pH Meter, and Analytical/Micro Balance. - Sample preparation and handling techniques. - Calibration, verification, and routine maintenance of laboratory equipment. - Ability to troubleshoot minor instrument issues. - Knowledge of method execution according to validated procedures. - Understanding of GMP, GLP, Good Documentation Practices (GDP), and Data Integrity (ALCOA+ Principles). - Knowledge of ISO 13485 and FDA 21 CFR Part 820 / Quality Management System requirements is preferred. - Knowledge of laboratory safety and chemical handling. - Strong attention to detail and adherence to quality requirements. - Good communication and teamwork skills. **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.