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The Position

Purpose

. Performance of testing of EM / product stream samples to meet product release timelines and in accordance with cGMP regulations and Roche/Genentech standards.

. 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.

Key Responsibilities

Technical and Functional:

. 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.

. Prepare EM trend graph periodically for trend data analysis.

. Operate laboratory autoclave and EM testing equipment.

. General lab support including housekeeping, equipment maintenance, document archival, maintaining logbooks and inventory of lab supplies, etc.

. Perform daily checks in EM LIMS to ensure all assigned EM tasks are completed and/or tested on time.

. Initiate discrepancy record for EM action excursion, adverse trend and/or discrepant event.

. Carry out assignments / projects given by Supervisor. Deliver results per plans / schedules.

. Communicate all problems / issues timely to Supervisor.

. Suggest improvements to streamline / facilitate workflows.

. Participate in internal / external audits and regulatory inspections.

. Responsible for ensuring that all training required to support / perform GMP activities are completed timely.

. Monitor and keep track of inventory stocks for laboratory consumables and items required.

. Perform sample receipt and storage of QC samples.

. Manage the life-cycle process for retain and reserve/reference samples.

. Manage and prepare the shipment of samples to Receiving labs.

Leadership:

. Work co-operatively with the Head of Micro/EM and QC Supervisor to create an environment of strong team spirit, timely and effective communications. Strive towards team's objectives / goals, takes the initiative and proactively turn ideas into action - to make things happen.

. 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.

. Embody PT behaviors, lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.

. A team player and the willingness to cover other colleagues in continued support of the Micro / EM operations.

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.

Quality Control Trainee - Attach & Train Program