QC Laboratory Specialist

3 weeks ago


Malvern, Iowa, United States Insight Global Full time

Job Title: QC Laboratory Specialist

Job Summary:

We are seeking a highly skilled QC Laboratory Specialist to join our team at Insight Global. As a QC Laboratory Specialist, you will be responsible for conducting biochemical and testing of raw material, in-process, final product release and characterization samples, including CAR-T.

Key Responsibilities:

  • Conduct analytical biological testing of clinical and commercial drug product/drug substance samples
  • Perform peer reviews and approvals of laboratory data
  • Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing including application of statistical concepts to laboratory data

Requirements:

  • Minimum one year of relevant GMP work experience in a lab setting
  • Bachelor degree in Biology or Chemistry
  • Working experience in a current Good Manufacturing Practices (cGMP) compliant QC laboratory or equivalent environment and solid understanding of cGMP and current Good Laboratory Practices (GLPs)
  • Experience with one or more of the analytical technologies used in the Cell and Gene Therapy Laboratories such as qPCR, cell culture, Flow Cytometry, and/or ELISA

What We Offer:

We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.



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