Thomas Berche Email & Phone Number

Orlando, Fl, Us

Orlando, Fl, Us

Mönchengladbach, North Rhine-Westphalia, De

Mönchengladbach, North Rhine-Westphalia, De

- Maintain, renew and participate in all ISO 15189 and 17025 accreditation procedures- Coordinate all internal/external proficiency testing procedures.- Develop/maintain SOP’s for applicability and implement/conduct training as appropriate- Supervise i.e. instrument maintenance, pipette calibration, personnel training, quality control evaluation, reagent lot management, temperature monitoring- Conduct internal audits in accordance with ISO standards.- Schedule and host external audits- Development of metrics to maintain continual improvement procedures- Conduct in-house personnel training- Supervision of over 20 hospital labs in all phases of quality management regarding ISO 15189 accreditation and/or quality requirements

- Provide guidance and training on GLP regulations, GCLP guidelines and company policies- Maintain and renew ISO 15189 and CAP/CLIA accreditation and GLP certification- Develop/maintain SOP’s for applicability and implement/conduct training as appropriate- Ensure that studies, methods and SOPs comply with all relevant regulations ad requirements- Manage root cause, corrective and preventive action implementation- Conduct, manage audit program to assure quality system adherence- Conduct vendor/subcontractor qualification audits.- Prepare written and signed records of all audits and inspections as required - Development of metrics to maintain continual improvement procedures- Conduct in-house personnel training