Job Description
Purpose
- 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). ...