Senior Quality Specialist: Lab Compliance Chemistry

Applies GMP/GLP in all areas of responsibility, as appropriateMonitor laboratory compliance with respect to expired reagents, reagent labeling, lab cleanliness, training records, PPE adherence, and other cGXP items, as needed to help minimize laboratory audit findings.Perform/Support Internal audits, as well as help, implement the resolution of internal/external audit findingsReview Instrument qualifications to ensure that work is performed as per the procedureReview and verify invalid data and system suitability failuresReview and close Exceptions under Non-Routine Events, System Suitability Failure, and DeviationsApprove Analytical Method/Protocol/SMIS/Client Parameter per QA procedureTrack and Analyze quality metrics (exception rate, rejection rate etc) and train laboratory personnel, as needed, to help reduce/eliminate reworkSupport other QA compliance-related activities, as neededDiagnose problems, solve simple problems, and suggest solutions to complex problems in the professional areaKeep oneself and peers abreast of current developments and trends in the professional area by reading and understanding internal procedures, attending training sessions, by writing/revising SOPs (as required), and by assisting Group Leader/Principal Specialists in training new employeesExercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process May serve as technical advisor for analysts with regard to QA/QC of dataCommunicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns