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Quality Assurance Specialist

2 months ago

Waltham, Massachusetts, United States ElevateBio Full time
About the Role

ElevateBio is a cutting-edge biotechnology company that specializes in accelerating the development of cell and gene therapies. We are seeking a highly skilled Quality Assurance Specialist to join our team and contribute to the success of our gene and cell therapy programs.

Key Responsibilities
  • Perform routine testing and analysis of cell and molecular biology assays in our state-of-the-art laboratory facilities.
  • Record and report data in our Laboratory Information Management System (LIMS).
  • Collaborate with cross-functional teams to ensure timely completion of testing and qualification of developed assays.
  • Assist in drafting and editing test methods and Standard Operating Procedures (SOPs).
  • Investigate and review testing excursions, including deviations, Corrective and Preventive Actions (CAPAs), and Out-of-Specification (OOS) results.
Requirements
  • Bachelor's or Master's degree in a technical discipline, such as Biology, Molecular Biology, or Chemistry.
  • Minimum 1-5 years of experience in a GMP Quality Control laboratory setting, preferably in cell and gene therapy test methodologies.
  • Excellent organizational skills and attention to detail.
  • Ability to work independently and communicate effectively with scientific and technical personnel.
  • Experience with laboratory investigations and knowledge of Good Manufacturing Practices (GMPs), SOPs, and Quality System processes.
  • Experience working with electronic systems, such as LIMS, CMMS, QMS, and ERP, is a plus.
About ElevateBio

ElevateBio is a technology-driven company that is committed to powering the creation of life-transforming cell and gene therapies. We aim to be the dominant engine inside the world's greatest scientific advancements, harnessing human cells and genes to alter disease. Our mission is to accelerate development across a breadth of therapeutic approaches and modalities, and our vision is to be the world's most indispensable cell and gene therapy technology company.

We are an equal employment opportunity employer and are committed to non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.