Quality Control Trainee - Attach & Train Program

3100 Roche Singapore Technical Operations, Pte. Ltd.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Roche in Singapore is seeking a dedicated professional to perform environmental monitoring (EM) testing and support manufacturing operations. The role involves EM for HVAC/BSC systems, sampling, and timely data review to ensure product release timelines in line with cGMP standards.

You will document results in LIMS, prepare trend analyses, and participate in internal/external audits. The position emphasizes robust housekeeping, inventory management, and adherence to SOPs to maintain high quality

Qualifications

• Perform EM tests in accordance with cGMP procedures.
• Review environmental, raw material and product samples per SOPs and TM.
• Document results in LIMS per cGMP procedures.
• Maintain lab inventory and housekeeping.

Responsibilities

• Perform EM monitoring for HVAC/BSC/HLFH/PMO systems as required.
• Test and review routine and non-routine samples per SOPs and Test Methods.
• Document results and maintain records in LIMS.
• Prepare EM trend graphs for data analysis.

Skills

Environmental monitoring

LIMS documentation

cGMP compliance

Data trend analysis

Education

Bachelor's degree in Life Sciences

Tools

LIMS

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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

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. 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. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.