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Form of workThe Role:
The QC Specialist I will support product release testing within the QC analytical laboratory at our basecamp facility in Waltham. In this role, you will be responsible for qualifying, writing/reviewing protocols for, and executing cell and molecular biology assays for elevatebio's gene and Cell Therapy programs. Additionally, the QC Specialist I will investigate and review excursions and deviations generated during qualification and testing.
Here's What You'll Do:
- Work cross-functionally with QC and Analytical Development to qualify and transfer developed assays.
- Draft and review qualification/validation methods as well as associated test methods/SOPs and reports.
- Perform routine analytical tests, analyze results, and record data/report in LIMS.
- Collaborate with other QC functions to ensure all testing is completed within established timelines.
- Investigate and review analytical testing excursions, including deviations, CAPAs and OOSs.
- Assist in the training of laboratory staff.
- Assist with QC-related batch disposition activities.
Requirements:
- Bachelor's, or Master's, degree in a technical discipline (Biology/Chemistry/Microbiology or related field) with a minimum of 5 years of experience, or 3 years with Master's degree. Experience in a GMP QC laboratory setting is preferred.
- Significant experience with cell and gene therapy test methodologies (PCR, Flow Cytometry, ELISA, and cell-based assays). Significant experience with flow cytometry is highly preferred.
- Experience drafting test methods and associated qualifications/validations.
- Experience performing laboratory investigations.
- Ability to work independently and communicate/collaborate with scientific/technical personnel.
- Excellent organizational skills and attention to detail.
- Significant knowledge of GMPs, SOPs, and Quality System processes.
- Experience in cell and gene therapy manufacturing environment is a plus.
- Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.
