Scientist II, Lab Document and Instrument Management

Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Location/Division Specific Information: * South San Francisco, CA * Genetic Sciences Division How will you make an impact? We are seeking a highly motivated candidate to join the Clinical Infrastructure and Laboratory operations team as Scientist II at our South San Francisco site.  This position offers a multi-skilled lab scientist an opportunity to join a growing team in our Genetic Testing Solutions group, specifically a dynamic team of R&D, Laboratory Management, and Quality Assurance professionals. The candidate will work with the team mainly to create laboratory documents and assist in managing the use of equipment, materials, and lab space, plus equipment maintenance and calibration. This individual may occasionally conduct pre-designed scientific or engineering experiments using laboratory equipment and calculations. In addition, the incumbent would assist in other duties required by the team, as needed. The successful candidate will help to ensure that the Genetic Testing Solutions operations run smoothly and follows safety, regulatory, and compliances standards. What will you do? * Creating new or optimizing existing laboratory procedures and test methods. Assisting in creating supporting documents, including protocols and reports in compliance with ISO13485 standards. * Creating and managing laboratory Standard Operating Procedures (SOPs) to ensure that all laboratory procedures and comprehensive documentation are conducted per laboratory standards. * Performing training of lab users to the standard operating procedures * Managing all laboratory equipment and ensuring maintenance and calibration complies with ISO and other regulatory standards. This includes assisting in managing equipment installation, IQ/OQ/PQ, and lab records. * With the assistance of the supervisor, ensuring that all operations are compliant with ISO13485 and other regulatory standards. * Advise supervisor of factors that may affect quality, accuracy, timeliness and usefulness of lab equipment. * Running tests and experiments in the laboratory; including processing human specimens to extract nucleic acids samples and running qPCR reaction plates on AB qPCR systems. * Major responsibilities are understanding and executing procedures, accurately recording data, and assisting in data analysis. How will you get here? Education/ Experience: * A degree in a Biological Sciences discipline and 3-5 years relevant experience. * Experience working in a lab environment under good laboratory practices. * Technical writing experience, including creation of project documents and process SOPs. * Understanding of ISO13485 laboratory regulations. * Familiarity with qPCR techniques and nucleic acid extraction methods. * Attention to detail and good organization skills. * Knowledge of Microsoft Office. * Must be flexible and comfortable working in a fast-paced environment. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. * EVRD2020 *GTSDouble

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