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
- Bachelors degree required, preferably in Science
- 2-3 years of relevant work experience, preferably in a regulated environment