Kyle R. Email & Phone Number

• Develop and execute documentation to support new client projects
• Review and support the transfer of client instructions for formulation/filling of their product and suggest improvements
• Support designing, specifying and validating equipment and processes
• Improve formulation processes and procedures
• Authoring and supporting quality events which could include deviations, non-conformances and client complaints.

San Diego County, California, United States

• Engage internally with multi-disciplinary teams to finalize design specifications
• Assess feasibility and lead time for new projects across different departments and optimize internal handling/processing
• Ensure on time delivery of results and products to customers
• Oversee custom productions to ensure project outcomes meets customer specifications while following GMP/ISO guidelines
• Input orders and create new part numbers in BioLegend Enterprise Resources Planning (ERP) database following ISO certified Standard Operating Procedures (SOPs)

• Develop presentations, procedures, and decision trees for instrument diagnosis and investigation.
• Collaborate on technical failure analysis investigations and identify corrective actions to preclude recurrence.
• Lead team to assess possible risks for unit failure modes and develop mitigation strategies to cut loss.
• Drive and develop quality processes to be used as part of ongoing operations
• Coordinate various projects across different departments to achieve product deliverables such as improving functionality and streamlining the inspection process for incoming/outgoing instrumentation (i.e. Firmware.
• Manage and set up laptops and printers for various lab needs and troubleshoot issues with the department.

• Ensure Quality Systems support for product development and product improvement projects,including validation testing, stability study execution, and documentation.
• Manage single largest customer order in company history of Sofia analyzers.

• Managing and processing biological samples to be used for researchand development.
• Design and develop lab experiments to test/ensure quality of lateral flow devices and reportdirectly to Director of R&D.
• Run quality control/assurance testing for clinical devices to validate accuracy of the product and documenting results.
• Creating solutions for analytical/qualitative purposes.