Environmental Monitoring Specialist
1 day ago
We are looking for an Environmental Monitoring Specialist to join our team. As an Environmental Monitoring Specialist, you will be responsible for performing testing of EM/product stream samples to meet product release timelines and in accordance with cGMP regulations and Roche/Genentech standards.
Key Responsibilities
- Perform routine and ad-hoc environmental monitoring (EM) works associated with HVAC/BSC/VLFH/HLFH monitoring, compressed air/gas, personnel monitoring, water, and clean/pure steam sampling.
- Support manufacturing operations by timely completion of testing and disposition.
- Continuous improvement of processes and technology to drive right first time and efficiencies.
Technical and Functional Requirements
- Perform EM which includes HVAC/BSC/VLFH/HLFH monitoring, compressed gas, personnel monitoring, water, and clean steam sampling in accordance to cGMP procedures.
- Perform 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).
- Documentation and review of results in the Laboratory Information Management System (LIMS) and/or documents in accordance with cGMP Procedures.
Leadership and Safety
- Work co-operatively with the Head of Micro/EM and QC Supervisor to create an environment of strong team spirit, timely and effective communications.
- Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health, and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
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