Associate II, Quality Control
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 II will support cellular therapy product release testing within the QC analytical laboratory at our BaseCamp facility in Waltham. In this role, you will be responsible for analytical testing (cell and molecular biology assays) as well as excursion/deviation investigations and reports in support of ElevateBio’s gene and cell therapy programs. Additionally, the QC Associate will assist in qualifying and writing protocols for these assays. This role is a Wednesday-Saturday 10-hour shift.
Requirements
- Bachelor’s, or Master’s, degree in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 3 years of experience, or 2 years with Master’s degree, preferably in a GMP QC laboratory setting.
- Experience with cell and gene therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and 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.
- Knowledge of GMPs, SOPs, and Quality System processes.
Nice To Haves
- Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.
Responsibilities
- Perform routine analytical tests, analyze results, and record data/report in LIMS.
- Investigate and review analytical testing excursions, including deviations, CAPAs and OOSs.
- Collaborate with other QC functions to ensure all testing is completed within established timelines.
- Work cross-functionally with QC Analytical Development to assist in the qualification and transfer of developed assays.
- Draft test methods/SOPs.
- Assist in the training of laboratory staff.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
