Edison-New Brunswick Metro Area, NJ
Job Title: Specialist, QA Shop Floor. CAR T team
Duties and Responsibilities:
Perform QA shop floor activities.
Ensure manufacturing compliance with applicable procedures and batch records.
Perform real time review of manufacturing batch records.
Review manufacturing shop floor documentation.
Issue production batch records and product labels to Operations.
Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
Must be skilled in planning and organizing, decision-making, and building relationships.
Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.