Posted in Other 13 days ago.
Job TitleQuality Assurance Specialist
RequisitionJR000011559 Quality Assurance Specialist (Open)
LocationST-Madison - USA504
Additional LocationsMadison, WI
The Quality Assurance Specialist is responsible for performing review of GMP documents and batch release as well as supporting the quality system processes and for maintaining quality assurance standards, processes, and controls. The Quality Assurance Specialist is also responsible for providing online support of manufacturing activities, and will occasionally be required to work in a cleanroom environment.
Department specific/Non-essential responsibilities:
Education / Experience / Skills:
The Quality Assurance Specialist collaborates closely with Manufacturing, Quality Control, Facilities, Materials Management, Clinical Quality, Regulatory Affairs, and Process Development. The individual must be able to perform in a fast-paced environment with strict adherence to timelines. This position reports directly to the Quality Assurance Manager. It is the expectation this position works during normal business hours M-F, but may be required to work extra hours or on weekends or holidays in order to support Manufacturing and Lot Release activities.
The Quality Assurance Specialist will mainly work in an office environment but will also be required to work in ISO Class 7 manufacturing and QC environment when providing QA support to those functional areas.