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.
Technical Responsibilities
- 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.
- Perform EM, including HVAC/BSC/HLFH/VLFH sampling, fingertips monitoring, compressed gases and water/clean steam sampling in accordance to cGMP procedures.
- Document and review results in the Laboratory Information Management System (LIMS) and/or documents in accordance to cGMP procedures.
- Review routine data and logbooks.
- Prepare trend graph for product lot release and trend data analysis.
Functional Responsibilities
- Perform sample receipt, chain of custody and storage of QC samples.
- Manage life‑cycle process for retain and reserve/reference samples.
- Manage and prepare shipment of samples to receiving labs.
- General lab support including housekeeping, document archival, maintaining logbooks and inventory of lab supplies.
- Initiate discrepancy record.
Other Functional Responsibilities
- Ensure timely completion of training required to support/ perform cGMP activities.
- Raise Work Notifications, follow‑up on planned receipt, delivery orders, invoices, etc.
- Participate in process improvement works.
- Contribute to continuous improvement of laboratory procedures and processes to ensure compliance to cGMPs.
- Participate in internal/external audits and regulatory inspections.
Teamwork & Safety
- Cooperate with the Head of Microbiology Operations, QC Ops Lead and teammates to create an environment with strong team spirit.
- Strive towards team's objectives/goals.
- Demonstrate initiative and proactively turn ideas into action – to make things happen.
- Engage in proactive measures to promote a positive safety culture and follow applicable Safety, Health and Environment requirements.
- Embed PT behaviors, lean principles and methods while fostering a continuous improvement mindset.
- Good team player with willingness to cover other colleagues in continued support of the Micro/EM operations.
- Comply with all RSTO's Safety, Health & Environmental (SHE) requirements.
- Observe all RSTO's site security measures at all times.
- Embed PT Lean Production System (LPS) with a continuous improvement mindset and behaviors.
Qualifications
- Degree holder with little or no prior relevant work experience.
- Knowledge of cGMP standards and laboratory safety procedures.
- Collaborative and proactive team player.
- Good verbal and written communication skills in English.
- Preferred willingness to work at Singapore Tuas Bay Link (Company shuttle bus is provided).
- Must be able to work weekends, off‑shifts and overtime as required.
EEO Statement
Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all.