QA Auditor at Thermo Fisher Scientific

Our QA team are seeking a GCLP Quality Auditor, to assess medical laboratory activities to assure that GCLP and contractual obligations to client companies are met. The successful individual will also to determine whether clinical trial laboratory testing is conducted and reported in accordance with GCLP Guidelines, regulatory requirements, and relevant PPD and client procedural documents. 

Responsibilities include:

• 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 degree.
• Valid professional license from a local professional body.
• 2 - 3 years of Experience in Quality or compliance environment in a medical laboratory, 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 or familiarity in ISO 15189 standards is an added advantage.
• Experience in microbiology, hematology, and clinical chemistry.
• Experience in GLP is useful with a preference for GCLP, and/or CLIA. 
• Working knowledge of Quality Assurance, GCLPs, or CLIA.
• Strong verbal and written skills in English. 
• Great organizational skills 
• Willing to travel at 50-70% capacity.