Job Description
Responsibilities
- Test EM/ product stream samples to meet release timelines, in accordance with cGMP regulations and Roche standards.
- Support manufacturing operations with 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.
- Support investigations of microbial contamination in production processes, classified environments and critical utility systems.
- Ensure test methods and data are generated in a cGMP, compliant manner.
- Understand basic microbiological principles (Bioburden, LAL, plating and counting techniques, etc.) and execution of intermediate techniques (DET, AET).
- Test and review routine and non‑routine environmental, raw material, product related samples in accordance to SOP and TM.
- Perfor...