Ross Fullerton Email and Phone Number

Write/issue validation protocols for laboratory analysis on a required platform according to company policy in a FDA (Food & Drugs Administration) & CAP (College of American Pathologists) accredited laboratory.• Experience includes: Routine/Special Chemistry, Infectious Disease, ELISA, Flow Cytometry, Hematology, Urinalysis, Immunology, Multiplex & Stability studies. Please refer to attachment for instrument/manufacturer specific experience.• Trained in Westguard Basic Method Validation & QC Practices, experienced in single assay and full instrument validation work. Performance characteristics of an instrument/analytical method are evaluated via linearity, sensitivity, precision, carryover, comparison and reference range studies. This requires establishing method tolerance, statistical review and interpretation of results.• Experienced in Quality Management providing lab support on a daily basis reviewing data points recorded electronically using the Bio-Rad Unity Real-time package. Westguard rules are adopted to identify both random and systematic error and any guidance/troubleshooting is provided to lab personnel. Monthly reports are generated comparing in-house methods to peer groups using both proficiency testing reviews and QC cumulative data. Biannual testing reports are generated for linearity and inter-lab comparison checks to ensure patient reporting is to a high quality standard.• Software systems QLIMS, ULTRA, iNET & Unity Real-time are utilized to provide high throughput automated testing and Quality Management. These systems allow for reference ranges to be accessed and also hold patient history details whilst reviewing and accepting clinical results.• This role requires decision making, daily liaising with management, planning and timely report writing, recording/presenting data for client review/audit (Word, Excel, Power Point). Communicating both internally/externally, global harmonization, logistics & stock control.