Quality Assurance Specialist

6 days ago


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

ElevateBio is a cutting-edge technology-driven company accelerating access to innovative genetic medicines. We're seeking a highly skilled Quality Assurance Specialist to support our gene and cell therapy programs.

Key Responsibilities
  • Execute testing and analysis of cell and molecular biology assays in our QC laboratories.
  • Perform peer-review of data and reports to ensure accuracy and compliance.
  • Investigate and review testing excursions, including deviations, CAPAs, and OOSs.
  • Collaborate with other QC functions to ensure timely completion of testing.
  • Assist in the qualification of developed assays and drafting/test methods/SOPs.
Requirements
  • Bachelor's or Master's degree in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with 1-5 years of experience.
  • 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/collaborate with scientific/technical personnel.
  • Experience performing laboratory investigations and knowledge of GMPs, SOPs, and Quality System processes.
  • Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.
About ElevateBio

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. We commercialize our enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities.

We're committed to equal employment opportunity and 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.



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