About Us CorDx, a multi-national biotech organization, focused on pushing the limits of innovation and supply in global health. With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious diseases such as COVID-19, pregnancy, drug abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Key Responsibilities 1. Laboratory Execution Conduct raw material screening, reaction system optimization, and performance verification for IVD assays and related products. Perform laboratory experiments according to established protocols and experimental design requirements. Support clinical trial activities by executing test procedures, recording data, analyzing results, and ensuring full adherence to study protocols. Maintain accurate, detailed laboratory notebooks, experimental records, and results reports. 2. Quality Control & Assurance Perform quality inspections and testing for raw materials, in-process samples, and finished IVD products. Prepare and issue inspection reports, documenting findings and managing non-conforming materials according to quality procedures. Maintain laboratory instruments, monitor cleanroom environments, and conduct routine water quality and process monitoring tests. Ensure all testing procedures are executed to meet internal quality standards and external regulatory requirements. 3. Documentation & Regulatory Compliance Prepare, update, and maintain technical documentation, including product registration dossiers, SOPs, system documents, and production standards. Support regulatory submissions for NMPA, FDA, IVDR, or other global compliance frameworks. Assist in product upgrades, process improvements, method validation, and verification activities. 4. Additional Support Activities Conduct literature reviews to support product development and scientific research initiatives. Perform routine maintenance of laboratory equipment and ensure a clean, organized, and safe laboratory environment. Participate in cross-functional team meetings, providing technical insights and experimental updates. Support ad hoc tasks and R&D project needs as assigned to help achieve departmental goals. Education Bachelor’s degree or higher in Biology, Medical Laboratory Science, Biotechnology, or a closely related field. Technical Skills Bilingual proficiency in English and Chinese (Mandarin/Cantonese) preferred. Strong understanding of biological laboratory operations, experimental procedures, and common laboratory instruments. Ability to design experiments, perform data analysis, interpret results, and independently complete technical reports. Proficiency in scientific literature search and interpretation. Familiarity with IVD product development processes and regulatory requirements (NMPA, FDA, IVDR) preferred. Experience Minimum of 1 year of laboratory or R&D experience in the IVD industry preferred. Outstanding recent graduates with relevant project or internship experience may also be considered. Comprehensive medical insurance. 401(k) plan with company contributions. Flexible paid time off (PTO) policy. #J-18808-Ljbffr
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