Quality Control Analyst

Company: Real Staffing
Location: Cambridge
Posted on: September 23, 2022

Job Description:

Quality Control Specialist (RE-33931988) Location:Cambridge, Massachusetts, United States Salary:US$70000 - US$90000 per annum + competitive Seeking a Quality Control Specialist to work with cell therapy projects. The Specialist will support raw material, in-process, release and stability testing for vaccines and cell-based assays. The successful candidate's primary responsible is to support new drug product development, method transfer/method validation of immunology/ cell-based assay according to GMP SOP. Job responsibilities:

• Process donor screening testing, release, and stability testing on cellular products/specimens according to standard operating procedure (SOP) using aseptic technique.
• Perform and analyze results of quality control testing of components, including automated cell counts and flow cytometry.
• Prepare reagents and materials for test methods.
• Participate in method validation and method transfer activities.
• Complete assigned deviations, CAPAs, Change Controls and laboratory investigations in a timely and efficient manner. Specific skills relevant to the job:
  • Cell count/viability
  • Cell based assays
  • Flow cytometry
  • qPCR Qualifications:
    • Bachelor's Degree and 1-3 years of regulated industry experience, or equivalent combination of education and experience.
    • Experience in Quality Control function in a GMP manufacturing operation.
    • Expertise in GMP compliance and FDA/EMA regulations. EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Keywords: Real Staffing, Cambridge , Quality Control Analyst, Professions , Cambridge, Massachusetts