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Quality Assurance Auditor – (Job Ref: 21/QALN)
We require a highly motivated and enthusiastic Auditor to work within the Quality Assurance Department.
This role is based in our RCLS Testing Lab in London.
Conduct Quality Audits, in particular internal ISO17025 Standard, reporting directly to Randox QA Manager.
Assist in the Management of Non-Conforming Work Identified within the RCLS Cubes and PODs Lab Sites to include the following:
• Act as Chair for the Quality discussion in the bi-weekly Management meeting held with the Randox Quality Assurance Department. This will include updating progress on any live CAPA Plans and overdue NCP’s in the RESPOND database and ensuring that NCP’s are managed in line with expected and documented timelines.
• Ensure that NCP’s in the RESPOND/QPULSE Database are progressed in line with documented procedure.
• Assist in the management of Internal Audits by progressing CAPA Plans in accordance with documented procedure alongside CAPA owners.
• Report to the RCLS Lab Manager/Quality Manager/Randox QA Manager on the CAPA Plan and NCP Progress and milestone achievement to CAPA Plans and NCP’s on a weekly basis.
• To assist in the writing of new Standard Operation Procedures and Work Instructions within the Department
• Monitor clinical documentation to ensure compliance with the quality regulatory requirements, in particular ISO17025.
• Participate in special projects and initiatives as requested by the Laboratory Manager following approval from Randox QA Manager.
• Adherence to company Positive Work Environment Policies, Health and Safety procedures, and the maintenance of a safe working environment.
Desired Skills and Experience
• Educated to Degree level (Life science degree desirable) or relevant experience.
• Previous experience of, or working in a, GMP, GLP, ISO 9001, ISO17025 or ISO 13485 related industry is essential.
• Experience in clinical diagnostic testing and reagent applications.
• Excellent communication skills (verbal and written) and ability to disseminate information in a concise manner throughout the Company.
• Proficient in use of Microsoft word, Excel, PowerPoint etc.
• Flexible approach and willingness to work outside hours if required.
• Experience in and a working knowledge of MDSAP and IVDR.
• Experience of auditing to ISO 13485 / ISO 17025 (ideally both).
Randox Laboratories is passionate about improving global health and saving lives through the development of innovative and pioneering products. Through our commitment and the skill of our people we have grown to be a world leader in diagnostics for clinical healthcare, toxicology, food security and providing quality solutions to over 145 countries. In order to serve our growing international markets we require high calibre applicants with scientific, engineering, software and broader business skills – including sales, marketing, logistics, finance and many more.
Central to the Randox ethos is our drive to improve healthcare worldwide and every one of our staff plays a vital role in this aim.