Mahedere Berhanu Email & Phone Number

• Responsible for reviewing and releasing final products and reagents • Lead QC team members and provides assistance as needed • Responsible for training QC specialists to perform various testing by following the proper procedures • Maintains close interaction with Customer Support Technicians and Product Technical Support groups to resolve field issues, investigate materials that did not meet specifications and hold meeting to discuss OCAPs• Work closely with Planners in order to determine schedules for QC team members based on the forecast• Hold scheduled meetings with QC team members throughout the day to discuss upcoming QC activities and to get updates on what have been accomplished for the day• Update documents for overall process improvements and better workflow

Carlsbad, Ca

Northbrook, Il

Insure that all generated laboratory work is in compliance with regulatory requirements Perform QSR testing of reagents and intermediates using prescribed methods to ensure samples meet pre-established acceptance criteriaConduct QC testing to resolve OOS issues, when applicable Conduct CAPA and nonconformance investigations and assists with NCR reportsPrepare and qualify various QC test samples required for various QC functional testing. Test samples include but are not limited to Coriell (CCL) DNA, DNA from whole blood and bacterial and viral targets Provide support in the development of assays, and manage to write Standard Test Methods (STMs) and Standard Operational Procedures (SOPs) and design tests that will aid in the proper training for the individuals using the STMs & SOPs. Conduct product stability testing and write reports Liaise with analytical chemistry, quality assurance, manufacturing , and R&D groups to meet all company requirements Generate data in compliance with regulations to be used in product submission to the FDA

Bachelor'S Degree, Chemistry Concentration In Biochemisty

Master'S Degree, Counseling Psychology

Bachelor'S Degree, Psychology