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• EAD (OPT/CPT/GC/H4)

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• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 22nd Jul 2021

They have a backlog of work and lab data/stability data they need to address.

Only need around 3-5 years of experience.  They need somebody with a biologics background.  A biologic/chemist degree will be great.  They will be supporting laboratory functions and data review.  This isn’t a validation/manufacturing role.  They need somebody with QA experience in a lab setting who has knowledge with GMP compliance.

 Key skills needed

• QA Laboratory compliance background
• Wet Chemistry
• Biological Assay
• Review of Laboratory data
• QA-Data Review
• Lab support functions

Experience in QA review of analytical data(release, in-process, and stability), experience in reviewing method qualifications/validations and the review and approval of laboratory investigations and deviations. Knowledge of USP, EU and JP cGMP guidelines.

This position is responsible for the compliance review of AFS (Analytical and Formulation Sciences) and Microbiology GMP data. This includes the review and approval of release, in-process, and stability test data.

This company is a biotechnology company that specializes in cell line development, process/analytical/formulation development, cell therapy, characterization, and clinical and commercial manufacturing.  This is a contract manufacturing organization.