Kelly Nester Email & Phone Number

Fremont, Ca, Us

Pleasanton, California

Fremont

- Support in the creation of parameters for assays on new and existing instruments for customer testing.- validation of new instrument parameters.- Validation for me and old assays on various instruments per customer demand.- Assist in bridging gap between Quality Department and Research and Development. - Build various batches of reagents, calibrators and controls for R&D testing purposes for design transfer and quality purposes.- Review reports for validation procedures and testing before it is sent to the customers and the FDA. - Work alongside managers and leadership team in managing projects for deadlines and submission to FDA.- Work cross functionally with Formulation Manufacturing and QC teams for troubleshooting issues based off of data summaries.- Extensive use of EP Evaluator, Microsoft Office, Agile, and QAD software.- Extensive use of clinical analyzes including: Hitachi 717, Hitachi 911, Hitachi 917, Abbott Architect c4000, Abbott Architect c8000, Beckman Coulter 480, Beckman Coulter DxC 600, Beckmann Coulter AU640, Beckman Coulter AU680, Beckman Coulter 5800, Ortho Clinical Diagnostics Vitros 4600, Ortho Clinical Diagnostics 5600, Siemens Vista 500, Thermo Scientific Indiko and Themo Scientific Indiko Plus, Thermo Scientific MGC240.- Exercise working knowledge of cGMP, ISO and FDA regulated environment.

- Manufacturing of calibrators and controls for multiple product lines and technologies. - Manufacturing of reagents for multiple product lines and technologies. - In process calibration and sample testing for Immuno Production and Quality Control. Including calibration of instruments, initial pilot data and verification for final product release.- Extensive daily use of instruments and analyzers for product testing and validation.- Review batch records for all departments and product lines.- Work alongside planners and managers for project due dates and upcoming order placement.- Helped develop and sustainable 5S organization project throughout the office area and laboratory. - Helped improve inventory control by 75% using a Kanban and water spider system.

- Daily procedure calls for use of GMP and GDP at all times.- Responsible for receiving and logging deliveries of controlled substances according to the FDA and DEA standards.- Developed a system for logging stability samples for controlled and precursor samples.- Maintain a log of lab standards and desiccator contents. - Maintain log of the chemist and analyst Laboratory Notebooks.- Use of SmartQC software. Putting all samples and project tests into the database for managers, chemists and analysts. - Coordinate plans for project due dates with managers and chemists. - Assist with disposal of hazardous material waste.- Accountable for shipments within and outside of the United States.

- Greet and check in customers, and writing detailed reports based on customer information.- Develop accurate estimates that include parts, labor and payment. - Prepare work orders for technicians, organizing and delegation work and tasks using technician report software.- Manage part returns to vendors and develop excellent vendor relations for sales and warranty contracts.- Maintain comprehensive filing system for all accounts, automotive and customer records. - Streamlined and upgraded filing system, increasing returns efficiency by 95%.