QC Specialist
PSC Biotech
Temporary
On-site
Boon Lay Way, South East, Singapore
Healthcare
Purpose<\/span><\/b><\/span>
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- Part of the Micro/EM Team responsible for the following:<\/span><\/span><\/span><\/span><\/span>
<\/span><\/span><\/li>- Performance of testing of EM / product stream samples to meet product release timelines and in accordance with cGMP regulations and Roche/Genentech standards.<\/span><\/span><\/span><\/span><\/span><\/span>
<\/span><\/span><\/li>- Support manufacturing operations by timely completion of testing and disposition.<\/span><\/span><\/span><\/span><\/span><\/span>
<\/span><\/span><\/li>- Continuous improvement of processes and technology, in collaboration with ASAT, to drive right first time and efficiencies.<\/span><\/span> <\/span><\/span><\/span><\/span><\/span><\/span><\/span>
<\/span><\/span><\/li>- Qualification and validation of test methods.<\/span><\/span><\/span><\/span><\/span><\/span>
<\/span><\/span><\/li>- Supporting investigations of microbial contamination in production processes, classified environments, and critical utility systems.<\/span><\/span><\/span><\/span><\/span><\/span>
<\/span><\/span><\/li>- Ensuring test methods and data are generated in a compliant manner following cGMPs. <\/span><\/span><\/span>
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<\/span><\/div>Key Responsibilities<\/span><\/b>
<\/span><\/div>- 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). <\/span>
<\/span><\/span><\/span><\/li>- Perform EM which includes HVAC / BSC / HLFH / VLFH sampling, fingertips monitoring, compressed gases and water / clean steam sampling in accordance to cGMP procedures when required.<\/span>
<\/span><\/span><\/span><\/li>- Documentation and review of results in the Laboratory Information Management System (LIMS) and/or documents in accordance with cGMP Procedures.<\/span>
<\/span><\/span><\/span><\/li>- Prepare EM reports / trend graph for product lot release and trend data analysis.<\/span>
<\/span><\/span><\/span><\/li>- Review routine data and logbooks.<\/span>
<\/span><\/span><\/span><\/li>- General lab support including housekeeping, equipment maintenance, document archival, maintaining logbooks and inventory of lab supplies, etc.<\/span>
<\/span><\/span><\/span><\/li>- Problem solving of testing related issues as well as troubleshooting of equipment.<\/span>
<\/span><\/span><\/span><\/li>- Author and/or update existing SOPs, Forms, OJTs and TMs as needed.<\/span>
<\/span><\/span><\/span><\/li>- Initiate discrepancy record, perform discrepancy assessment and identify corrective actions where necessary.<\/span>
<\/span><\/span><\/span><\/li>- Train other analysts on methods and/or SOP.<\/span>
<\/span><\/span><\/span><\/li>- Responsible for ensuring that all training required to support / perform GMP activities are completed timely.<\/span>
<\/span><\/span><\/span><\/li>- Participate in internal / external audits and regulatory inspections.<\/span><\/span><\/span>
<\/span><\/li>- Raise work notification, g2g shopping cart for purchase of consumables / reagent / media for Lab use. Follow up on the planned receipt, Delivery orders, invoices when required.<\/span><\/span><\/span><\/span><\/span>
<\/span><\/li>- Understanding of basic microbiological principles (bioburden, LAL, plating and counting techniques, etc) and execution of intermediate techniques (DET, AET).<\/span><\/span><\/span><\/span><\/span><\/span><\/span>
<\/span><\/li>- Participate in project, validation and process improvement works.<\/span><\/span><\/span><\/span><\/span><\/span><\/span>
<\/span><\/li>- Perform equipment qualification / maintenance, liaise with external / contract lab / vendor.<\/span><\/span><\/span><\/span><\/span><\/span><\/span>
<\/span><\/li>- Contribute to the continuous improvement of laboratory procedures and processes to ensure compliance to GMPs.<\/span><\/span><\/span><\/span><\/span><\/span><\/span>
<\/span><\/li>- Provide forecast for consumables / reagent / media used and facilitate in budgeting and financial planning.<\/span><\/span><\/span><\/span><\/span><\/span><\/span>
<\/span><\/li>- Perform sample receipt and storage of QC samples.<\/span><\/span><\/span><\/span><\/span><\/span><\/span>
<\/span><\/li>- Manage the life -cycle process for retain and reserve/reference samples.<\/span><\/span><\/span><\/span><\/span><\/span><\/span>
<\/span><\/li>- Manage and prepare the shipment of samples to Receiving labs.<\/span><\/span><\/span>
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<\/span><\/span><\/span><\/span><\/span><\/li><\/ul>Leadership<\/span>
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<\/span><\/div>- 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. <\/span>
<\/span><\/span><\/li>- 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.<\/span>
<\/span><\/span><\/li>- Embody PT behaviors, lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.<\/span>
<\/span><\/span><\/li>- A team player and the willingness to cover other colleagues in continued support of the Micro/EM operations.<\/span>
<\/span><\/span><\/li><\/ul>
<\/span><\/div>Safety, Health & Environment<\/span> - 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.<\/span>
- Perform EM which includes HVAC / BSC / HLFH / VLFH sampling, fingertips monitoring, compressed gases and water / clean steam sampling in accordance to cGMP procedures when required.<\/span>
- Performance of testing of EM / product stream samples to meet product release timelines and in accordance with cGMP regulations and Roche/Genentech standards.<\/span><\/span><\/span><\/span><\/span><\/span>