Part of the Microbiology/ Environmental Monitoring (EM) team responsible for the following:

• 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.

The Opportunity:

Technical:

• 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 the Standard Operating Procedures (SOP) and Test Methods (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:

• Perform sample receipt, Chain of Custody and storage of QC samples.
• Manage life-cycle process for retain and reserve/ reference samples.
• Managed and prepare shipment of samples to Receiving labs.
• General lab support including housekeeping, document archival, maintaining logbooks and inventory of lab supplies, etc.
• Initiate discrepancy record.

Others functional:

• Ensuring 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.
• Participates in internal/ external audits and regulatory inspections.

Teamwork:

• Cooperates 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.
• Demonstrates initiative and proactively turn ideas into action - to make things happen.
• Engage in proactive measures to promote a positive safety culture and follows applicable Safety, Health and Environment requirements.
• Embody 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.

Safety, Health & Environment:

• Comply with all RSTO's Safety, Health & Environmental (SHE) requirements.
• Observe all RSTO's site security measures at all times.

Lean Production System:

• Embody PT Lean Production System (LPS), with a continuous improvement mindset and behaviors.

Who You are

• Entry Level, Diploma in Microbiology, Biology, Biochemistry or equivalent, or GCE 'A' Levels (Science) with little or no prior relevant work experience.
• cGMP standards and laboratory safety procedures
• A collaborative and proactive team player
• Good verbal and written communication skills in English

Preferred

• Willing to work at Singapore Tuas Bay Link (Company shuttle bus is provided).
• Must be able to work weekends, off-shifts and overtime as required.