Assistant QC Scientist. - TSR Consulting Services, Inc.

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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