Manufacturing QMS Specialist

Job description

Description The Manufacturing QMS Specialist , is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC. This position is located in Chicago, IL. Under the direction of Manufacturing Management, the Manufacturing QMS Specialist will be executing routine documentation work which includes writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPAs etc. This position requires technical expertise in the upstream and downstream process of biologics (Cytokines, monoclonal antibodies manufacturing). Essential Duties & Responsibilities: - Will be responsible for supporting the manufacturing team with all kinds of documentation. - Documentation includes reviewing executed batch records (both Upstream department and Downstream batch record). - Will be responsible for filing change controls, Deviation, and CAPA for manufacturing department. - For all critical / major investigation, will have to use investigation tools like 5Why or 6M method. - Attend daily meetings with both upstream and downstream process to get all the documentation requirements for the day. - Will meet weekly with QA to avoid any delay in the QMS closure. - Wi...