QA GCLP Auditor I/II at Thermo Fisher Scientific

About The Role

The GCLP Quality Auditor assess medical laboratory activities to assure that GCLP and contractual obligations to client companies are met and determines whether clinical trial laboratory testing is conducted and reported in accordance with GCLP Guidelines, regulatory requirements, and relevant PPD and client procedural documents.

• Performs routine GCLP audits. Work assignments include multiple therapeutic indications across different projects and clients.
• Conducts a variety of client, internal, or GxP audits and supports regulatory inspections as requested by senior management
• Participates in process audits
• Performs other types of QA audits or activities (e.g., database audits, clinical study report audits, sample results tables, facility audits, process improvement)
• Serves as a resource to operational departments on audit or quality assurance subject matter
• Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings.

Education And Experience

• Bachelor’s degree in Medical Technology, or other related laboratory sciences. ASCP certification is an added advantage
• 2 - 3 years of Experience in Quality or compliance environment in a medical laboratory or pharmaceutical company and a previous experience in audit activities is an asset as well as the knowledge of the GCLP guidelines from DAIDS, BARQA and/or EMA/INS/GCP/532137/2010
• Experience in microbiology, hematology, and clinical chemistry
• Experience in GLP useful with a preference for GCLP, and/or CLIA.
• Working knowledge of Quality Assurance, GCLPs, or CLIA.
• 10 years’ experience with clinical laboratory operations, deliverables, and services (Laboratory Equipment/Instrumentation, Testing Facility Operations, Laboratory Information Systems, Laboratory Safety, Quality Management Systems, Records and Reports, Specimen Management and Tracking and Verification of Performance Specifications)
• Strong verbal and written skills in English. Individual with additional language skills in Thai/ Vietnamese will be highly considered.
• Great organizational skills
• Must be willing to travel internationally (post-pandemic) at 50-70% capacity. Local travel is expected during the pandemic.