Clinical Trials Quality Control Specialist

Job description

Job Title: Clinical Trials Quality Control Specialist Department: Specimen Processing: Location: Onsite, Rochester, NY: Hours Per Week: 40: Schedule: Days; Monday - Friday: SUMMARY: The Quality Control Specialist is responsible for the oversight and management of quality control standards for Clinical Trials Specimen Management. The Quality Control Specialist will work collaboratively with the CTSM supervisors and Team Leads to ensure quality and best practices in the laboratory. This position reports to the Director of Laboratory Operations. RESPONSIBILITIES: - In coordination with Management keeps up with-current understanding of all applicable regulations, requirements and standards in regards to quality control processes. - Performs all work in accordance with requirements of regulatory agencies such as CAP, NYSDOH, CLIA, OSHA, ISO and ISBER. - Participates in CT Lab and CT Specimen Management (CTSM) quality control investigations, root cause analysis, corrective/ preventative actions, and process improvements for the Lab and CTSM. - Works with Lab and CTSM leaders to develop and maintain quality dashboards, quality monitors, regulatory (CAP, NYSDOH) related tasks, key performa...