Associate I, QC Analytics (Contract, Multiple Positions)

ElevateBioWaltham, MA
$33 - $48Onsite

About The Position

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. The QC Associate will support GMP testing in QC laboratories at our BaseCamp facility in Waltham. In this role, you will be responsible for performing cell and molecular biology assays, as well as basic laboratory maintenance in support of ElevateBio’s gene and cell therapy programs. Additionally, the QC Associate may assist in qualifying these assays.

Requirements

  • Bachelor’s, or Master’s, degree in a technical discipline (Biology/Molecular Biology/Biochemistry/Chemistry or related field).
  • 1-5 years of experience with a Bachelor’s, 1-3 years with a Master’s.
  • Experience working in a GMP setting preferred.
  • Experience with cell and gene therapy test methodologies (i.e. PCR, Flow Cytometry, ELISA, cell culture, cell-based assays).
  • Excellent organizational skills and attention to detail.
  • Ability to work independently as well as communicate and collaborate with scientific/technical personnel.
  • Experience performing laboratory investigations.
  • Knowledge of GMP, SOPs, and Quality System processes.

Nice To Haves

  • Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.

Responsibilities

  • Perform routine testing using established test methods, analyze the results, and record/report the data.
  • Perform peer-review of data records and testing reports.
  • Assist with investigating and reviewing testing excursions, including deviations, CAPAs and OOSs.
  • Collaborate with other QC functions to ensure all testing is completed within established timelines.
  • Share responsibility with peers to manage inventory and reagents, and perform maintenance and other daily lab operations.
  • Work cross-functionally with Analytical Development and other QC functions to assist in the qualification of developed assays.
  • Assist in drafting and/or editing procedures for testing and/or equipment.
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