Assistant QC Scientist.

1 month ago


Warren, United States TSR Consulting Services, Inc. Full time

81024


TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.


Our client, a leading pharmaceutical company is hiring an Assistant QC Scientist. Please ONLY local candidates to Warren NJ.


Required Skills:

  • 2+ years of hands-on experience with bioanalytical techniques such as ELISA, Potency, Cell based assays, etc.
  • 1+ year experience working in regulated environment (e.g. cGMP, cGLP)
  • Previous Assay Transfer, assay validation experience
  • Previous CAR-T experience preferred
  • Technical understanding and troubleshooting skills
  • Experience/knowledge in deviation, CAPA, Change Control


Work Location: Warren NJ


Pay: $40-41/hour W2


Responsibilities:

  • The QC Analyst is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products
  • Experience in assay transfer, technology transfer, validation from Analytical Developmental group to Quality Control group
  • Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements
  • Technical writing skills
  • Perform testing of in-process, final product, stability samples, and method transfer
  • Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment
  • Document training per procedural and cGMP requirements
  • Perform assigned tasks within a CAPA, deviation, or project
  • Draft and review technical documents, such as SOPs and forms
  • Bachelor’s degree required, preferably in Science
  • 2-3 years of relevant work experience, preferably in a regulated environment



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