Dynamic chemist with a strong background in clinical diagnostic chemistry and expertise spanning clinical research, product development, and clinical laboratory operations. Experienced in FDA validation and verification of chemistry analyzers, with a throuough understanding of CLIA compliance and CLSI guidlines. Recognized for exceptional cross-functional communication, patient-centered care, and customer service. Eager to pursue opportunities that foster professional growth and expand scientific expertise.
Provide support during the FDA validation and verification of the BioPlex Next chemistry analyzer. This includes performing value assignment of bulk material, precision studies, and software stability testing. Responsible for maintaining multiple analyzers and provide detailed reports on the status of each analyzer for R&D purposes.
Oversaw quality control processes for sample handling and equipment maintenance to ensure regulatory compliance and thorough documentation. Acted as a liaison between project management and clinical laboratory to enhance workflow efficiency. Managed patient scheduling and delivered exceptional customer service support.
Performed daily quality control on laboratory instruments. Processed patient information using laboratory information systems (LIS). Assisted in clinical research studies and maintained inventory. Drafted standard operating procedures (SOP) and supported proper laboratory documentation.