Role / Job Description
Conduct testing of new or modified hematology analyzers/reagents, testing includes reagent stability testing, raw material characterization, Test Method validation, Quality Control, Calibration and analysis of whole blood samples.
Prepare test procedures and reports, documents the execution of the test procedures and test results in accordance with departmental procedures and requirements specifications.
Prepare reagent/control bench batches and Development Scale up lots.
Assist with trouble shooting product performance issues by working with cross functional teams.
Analyze data using statistical methods, interprets technical data; reports and documents issues, and collects data for to support global registration of consumable.
Must be experienced working within a regulated environment and follows all safety procedures and policies in the laboratory.
Working experience in a medical laboratory; General laboratory workflow
Reviewing Hematology Results, including CBC, 5 Part Differential, and Flagging;
Reagent pooling and filling
Experience with GLP and GMP
Knowledge of basic laboratory statistics
Proficiency in Microsoft Office
Able to work within an agile environment.
Project planning skills
Should have experience with pH meter, Osmometer, Conductivity Meter, Spectrophotometer, HPLC (preferred), Beckman Coulter Particle Counter (preferred)
Minimum of a Bachelor’s degree in Medical Science Technology or other relevant baccalaureate degree and 5+ years of relevant experience, or Master’s degree(s) and 3+ years of relevant experience, or PhD and 1+ years of relevant experience.