- Optionales Büro in Alpharetta
Description
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 & Technical Responsibilities
- Perform laboratory testing and experimentation related to lateral flow (chromatographic) diagnostic products, including but not limited to assay preparation, testing, troubleshooting, and optimization.
- Execute routine and non-routine testing to support product development, verification, validation, and performance evaluation.
- Accurately document experimental procedures, observations, and results in laboratory notebooks, controlled forms, and electronic systems in compliance with quality system requirements.
- Assist in reagent preparation, sample handling, equipment calibration, and laboratory maintenance.
2. Product Design & Development Support
- Support various stages of the IVD product design and development process, from feasibility and prototyping through verification and validation.
- Collaborate with R&D, Quality, and Regulatory teams to ensure development activities comply with applicable sections of ISO 13485 and 21 CFR Part 820 (Quality System Regulation).
- Contribute to design inputs, design outputs, risk management activities, and design change documentation as required.
3. Evaluation Protocols & Performance Testing
- Execute testing activities in accordance with Evaluation Protocol (EP) documents for analytical and clinical performance evaluation.
- Apply EPs to assess performance characteristics such as sensitivity, specificity, accuracy, precision, reproducibility, robustness, and stability.
- Support data analysis and summary reporting for internal reviews, regulatory submissions, and design history file (DHF) documentation.
4. Quality & Compliance
- Follow Good Documentation Practices (GDP) and laboratory best practices.
- Adhere to CorDx quality policies, standard operating procedures (SOPs), and safety requirements.
- Participate in audits, inspections, and internal reviews as needed.
Requirements
Education
- Bachelor’s degree or higher in Biology, Medical Laboratory Science, Biotechnology, or a closely related field.
Technical Skills
- 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 2-3 years of laboratory or R&D experience in the IVD industry preferred.
Benefits
- Comprehensive medical insurance.
- 401(k) plan with company contributions.
- Flexible paid time off (PTO) policy.
