QC Specialist I, Viral Vector
Our client is a cell and gene therapy technology company built to power the development of transformative cell and gene therapies today and for many decades to come.
In this lab-based role, the QC Specialist I will support product release testing within the QC analytical laboratory. You will be responsible for qualifying, writing/reviewing protocols for, and executing cell and molecular biology assays 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 Analytical Development to transfer and qualify developed assays
- Lead drafting and review of methods, and qualification/validation procedures and reports for cellular assays such as Flow Cytometry
- Perform routine molecular and cellular analytical tests; review, analyze, and communicate results
- Investigate and review analytical testing excursions including deviations, CAPAs and OOSs
- Assist in the training of laboratory staff
- Collaborate with other QC functions to ensure all testing is completed within established timelines
- Bachelor’s, or Master’s, degree in a technical discipline (Biology/Chemistry/Microbiology or related field) with a minimum of 3 years of experience, or 1 years with Master’s degree
- Experience in a GMP QC laboratory setting is preferred
- Experience with techniques such as PCR, Flow Cytometry, immunoassays, cIEF required
- Significant experience with flow cytometry is strongly preferred
- Experience in a GMP QC laboratory setting and/or drafting of test methods and qualifications is strongly preferred
- Excellent organizational skills and attention to detail
- Ability to work independently and communicate/collaborate with scientific/technical personnel
- Significant knowledge of GMPs, SOPs, and Quality System processes.
- Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus