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Quality Control Specialist
2 months ago
ElevateBio is a cutting-edge biotechnology company that is revolutionizing the field of cell and gene therapy. Our mission is to accelerate the development of life-transforming treatments that will change the future of medicine.
The Role:
The Quality Control Specialist will play a critical role in supporting the testing and validation of cell and gene therapy products at our state-of-the-art facility. In this position, you will be responsible for executing testing protocols, analyzing results, and recording data in our laboratory information management system (LIMS). You will also be involved in peer-review of data and reports, as well as investigating and reviewing testing excursions, including deviations, corrective and preventive actions (CAPAs), and out-of-specification (OOS) results.
Key Responsibilities:
- Perform routine testing and analysis of cell and gene therapy products
- Record data and results in LIMS
- Peer-review data and reports
- Investigate and review testing excursions, including deviations, CAPAs, and OOS results
- Collaborate with other quality control functions to ensure timely completion of testing
- Assist in the qualification of developed assays
- Contribute to the development and maintenance of test methods and standard operating procedures (SOPs)
Requirements:
- Bachelor's or Master's degree in a technical discipline (biology, molecular biology, chemistry, or related field) with a minimum of 1-5 years of experience, or 1-3 years with Master's degree, preferably in a GMP quality control laboratory setting
- Experience with cell and gene therapy test methodologies (i.e., PCR, flow cytometry, cell-based assays)
- Excellent organizational skills and attention to detail
- Ability to work independently and communicate effectively with scientific and technical personnel
- Experience performing laboratory investigations
- Knowledge of good manufacturing practices (GMPs), SOPs, and quality system processes
- Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus
Why ElevateBio?
ElevateBio is a technology-driven company that is committed to powering the creation of life-transforming cell and gene therapies. We are dedicated to accelerating the development of advanced treatments that will change the future of medicine. Our mission is to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.
Our Vision:
We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created, and how disease is treated.