COMPANY DESCRIPTIONWe are a leader in liquid biopsy. Every day we transform the lives of cancer patients and their families through the power of liquid biopsy. Our tests unlock essential genomic information from a simple blood test and allow clinicians to make more informed treatment decisions for their patients.We are dynamic and innovative, focused on the development of new ground-breaking technologies in a fast-paced and international setting. Our exceptional team of talented and driven individuals work together to combine their energy and expertise in world-class research, product development and commercialization to bring new tests to the patients that need them.If making a difference is in your DNA and you are ready to join the liquid biopsy revolution, then you could be just the person we are looking for to join our team based in Cambridge, UK!POSITIONRole Overview:The Quality Control Specialist will play an integral part in performing Quality Control (QC) test methods and working with the clinical laboratory and clinical assay transfer teams to define specifications for purchased and in-house manufactured reagents and consumables. The high complexity nature of the work requires knowledge about reagent QC testing, analytical NextGen Sequencing methods and technology, and regulatory requirements. This role will also contribute to the development of new products, new processes, and in ensuring the consistent quality of materials used in sample testing within Inivata’s Clinical Laboratory.This role will participate in group efforts to create and implement quality testing methods, stability data, and standard operating procedures to ensure that any quality issues with reagent or consumable lots are discovered and addressed PRIOR to their use in our Clinical Laboratory. The Quality Control Specialist will collaborate with cross-functional teams in the investigation of reagent quality issues and help drive continual improvement in efficiency and effectiveness of QC methods. (Robust System for Incoming Release of Materials).Key Responsibilities:Support reagent QC testing activities for analytical NGS methods and technologyAssist with writing and revising Quality Standard Operating Procedures to comply with regulatory requirementsAssist with the generation of documentation for equipment acceptance, material acceptance, batch records, and assay validationsManagement of material inventory for UK laboratoryPerform data entry into Laboratory Information Management Systems (LIMS)Support the qualification, preventative maintenance and calibration of instruments according to servicing schedulesLiaise with external contractors assigned to perform servicing activitiesCollaborate with Clinical, Assay Development, Manufacturing and Quality team membersPromote quality awareness and commitment to quality within the Clinical LaboratoryPerform miscellaneous tasks as assignedHIPAA/GDPR Compliance: Position willAgree to abide by Employment and Confidentiality Agreements and End User PoliciesCommit to stay up to date on training requirements for HIPAA/GDPRUnderstand the importance of the proper handling and disposal of ePHI and agrees to follow HIPAA/GDPR RegulationsAbide by the requirements for the proper disposal of equipment containing ePHIAgree to report breaches and the improper handling of ePHI to the Company’s Privacy and Security OfficersProduce and adhere to proper validation documentationREQUIREMENTSTechnical Requirement:Bachelor’s degree in Biology, Chemistry, or related field.Reagent Quality Control experience is required.2-4 years of relevant molecular biology experience in a laboratory setting is preferredSkill requirement:Desired experience in a molecular-based clinical diagnostics laboratory managing inventory and reagent quality control processesAn understanding of regulatory requirements for materials managementAn understanding of Quality System Regulation requirements and GMP working environmentFamiliarity or proficiency with IVD reagent manufacturing and qualification.Proficiency in the use of computers and Microsoft Office ApplicationsData entry experience with Laboratory Information Systems (LIS) and/or Laboratory Information Management Systems (LIMS)IVD experience (reagents and assays) preferred with demonstrated ability working in a team environmentProven organisational skills to handle multiple tasks and ability to communicate cross-functionallyOTHER INFORMATIONOur Values guide all our activities:We are BOLD with the delivery of cutting edge science.We are PASSIONATE we love what we do, our purpose and our impact on patients is clearWe are CARING we care for our patients, our partners, customers and colleaguesInivata Limited is based in Cambridge, UK.No agencies please.www.inivata.comWe look forward to reviewing your application!To apply for this job please visit cezanneondemand.intervieweb.it.