Overview The Sr Supervisor Reagent Manufacturing is responsible for the day-to-day supervision of Reagent Manufacturing departments and leading Quality Control (QC) procedures in the non-technical clinical section of the laboratory under the general direction of the Manager of Operations Support and Laboratory Director. The Sr Supervisor Reagent Manufacturing is accountable for supervising non-technical personnel, making sure reagent manufacturing and quality control procedures are performed as documented by trained personnel to ensure accurate reporting and identifying and implementing process improvements. Ensures that all materials pass QC validation prior to being used in production, ensuring paperwork is completed correctly and on time, ensuring processes are performed according to approved Standard Operating Procedures, and ensuring that sufficient QC'd reagents are available for patient testing.

CLIA Title:New York State Title:  

      N/A   N/A Internal Classification: Non-technical Responsibility * Ensure laboratory compliance with technical, operational, administrative, and safety policies. * Plan and supervise daily operations of the QC team to make sure procedures are performed accurately and efficiently. * Ensure all raw materials used in the lab are properly prepared, QC'd, and stored prior to use in patient testing. * Ensure that Master Mixes are prepared, dispensed, and evaluated according to current SOP. * Ensure that plates are prepared and evaluated and stored in enough quantities to keep the lab in operation. * Ensure all documentation and electronic records related to QC activities are accurate and complete. * Identify and follow cost saving measures. * Prepare the manufacturing plan and ensure it is executed correctly. * Ensure the capacity of manufacturing is enough to comply with the volume growth of product/s supported. * Ensure that stability studies for Master Mixes are performed and filed as needed. * Work with the Supply chain Team to monitor inventory levels of manufactured reagents and ensure adequate supply for Lab use. * Ensure proficiency samples are processed in the lab. * Track inventory of raw materials needed for manufacturing and work with Supply chain personnel to place orders as needed. * Approve release of raw materials and sub-assemblies for use in finished goods. * Work with Lab Development, Automations, and RandD to troubleshoot and improve production Lab processes. * Work with Lab Development to validate new test methods and develop the QC/manufacturing process for those new test methods. * Ensure patient samples are discarded at proper interval/per special request. * Oversees troubleshooting efforts with the QC and reagent manufacturing laboratory. * Directly interact with vendors regarding quality concerns of reagents. * Define user requirements and lead UAT for QC related functions in LIMS and EDM reports. * Perform and participate in non-conformance investigations as needed. * Development and implementation of departmental... For full info follow application link.

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