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Job Description
Purpose: Part of the Micro/EM Team responsible for performing testing of EM/product stream samples to meet product release timelines and in accordance with cGMP regulations and Roche/Genentech standards. Support manufacturing operations by timely completion of testing and disposition. Continuous improvement of processes and technology, in collaboration with ASAT, to drive right first time and efficiencies. Qualification and validation of test methods. Supporting investigations of microbial contamination in production processes, classified environments, and critical utility systems. Ensuring test methods and data are generated in a compliant manner following cGMPs.
Responsibilities- Testing and review of routine and non-routine environmental, raw material, product-related samples in accordance to the SOPs and test methods.
- Perform EM which includes HVAC, BSC, HLFH, VLFH sampling, fingertips monitoring, compressed gases and water/clean steam ...