QC Specialist I, Viral Vector

QC Specialist I, Viral Vector
Waltham, MA

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. 

The Role:

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

Requirements:

  • 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