• US Citizen

• Green Card

• EAD (OPT/CPT/GC/H4)

• H1B Work Permit

• Corp-Corp

• Consulting/Contract

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 6th Aug 2022

Managing the qualification of various Analytical Laboratory Instruments and Software including HPLCs, UPLCs, UV-vis, GCs, Ovens, Karl Fischers, FTIRs/Empower, Agilent ChemStation, Omnic software with a focus on data integrity.

Desired Skills and Experience:

4+ years of Project Management and relevant industry experience in cGMP/Biotech/Pharmaceutical Manufacturing/FDA regulated industries
Bachelor’s degree or higher in Engineering, Life Sciences, or related discipline (Engineering, Chemical Engineering, Chemistry, Biology, etc.)
Knowledge of FDA regulations, application of cGMP and cGDP.
Understand industry standards related to validation.
Ability to write detailed investigation reports and qualification/validation documents that consistently meet Company and regulatory agency requirements.
Verbal and written communication skills. Must be able to read, write, and converse in English.