QC Specialist

• Part of the Micro/EM Team responsible for the following:
• Performance of 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.

• Testing and review of routine and non-routine environmental, raw material, product related samples in accordance to the Standard Operating Procedures (SOP) and Test Methods (TM). ...

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