Reagent QC Technician 3

4 weeks ago

Singapore ILLUMINA SINGAPORE PTE. LTD. Full time
Roles & Responsibilities

Position Summary:


Reagent QC Technician 3 (RQCT 3) is responsible for executing operational activities including setting up and maintenance of equipment in compliance with cGMP, quality & safety requirements to achieve operational objectives. This role encompasses a broad spectrum of analytical, molecular, and biochemical techniques to evaluate product quality. RQCT 3 is also required to assist in incident investigation and engineering study. RQCT 3 is also required to conduct training for new employees and lead a small team in troubleshooting to meet production target at a specific area.


Position Responsibilities:


• Complete required training (e.g. cGMP, safety and work instructions, etc.) within a stipulated time frame.
• Ensure proper housekeeping and maintain cleanliness (6S) of the working area.
• Execute tasks strictly following cGMP, Quality, Safety and Work instruction requirements.
• Ensure employees follow safety, quality requirements, and all applicable company policies at all times.
• Timely report/ escalate any concerns (work-related or personal).
• Able to take on additional tasks or responsibilities when required.
• Primary reviewer of batch records for final product release.
• Perform and guide others on daily QC routine tasks (e.g. QC sample collection).
• Conduct and guide others on analytical, molecular and biochemical analysis for intermediate and final products (reagent samples).
• Prepare and guide others on reagent samples using basic laboratory equipment in accordance with Work Instruction (WI).
• Able to test and guide others on preparing reagent samples using different laboratory analytical instruments in accordance with Work Instruction (WI).
• Generate and analyze test results (example: Chromatogram) in accordance with Work Instruction (WI). At the same time providing guidance to others.
• Ensure accurate data generation and entry of records into Manufacturing Execution System (MES) or Laboratory Information Management System (LIMS). At the same time providing guidance to others.
• Perform and guide others on regular maintenance / inspection of measuring devices and equipment for accuracy.
• Perform and guide others on peer verification to ensure test / inspection process follow Work Instruction (WI).
• Perform and guide others on basic troubleshooting of common issues and investigation of reagent sample failure (Out of Specification) to determine the root cause and perform immediate corrective actions.
• Able to guide others on the preparation, qualification and tracking of oligos and standards to ensure sufficient and non-expired inventory for sample analysis.
• Prepare and guide others on chemical stock solutions and reagents for analysis.
• Guide others to verify inventory records of all control and consumable are updated.
• Guide others in procurement, purchasing duties according to inventory records.
• Train and guide new technician on QC testing processes defined in work instruction(s).
• Improvement work:
o Participate and guide others in process improvement to enhance manufacturing/QC process capabilities in area such as quality and efficiency.
o Assist and guide others in non-production activities such as engineering studies, NCR investigation runs, validation / PPQ runs.
o Involve in work instruction review under some guidance.
• Incident investigation and reporting
o Participate in incident investigation and be able to provide a summary report under direct guidance.
o Able to organize the objectives and structure of the report, drafting and proofreading to improve the report under some guidance.
o Report abnormalities and support investigation of nonconforming material under some guidance.
• Learning and Development
o Apply workplace learning techniques to enhance employees' development with broad guidance.
• Be a role model for Reagent QC Technician 1-2.


Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements:


• Complete tasks in a safe and efficient manner.
• High level of discipline and integrity.
• Able to undergo job rotation/cross training.
• Able to work in noisy environment with appropriate personal protection equipment (PPE).
• Able to work in chemical environment with appropriate personal protection equipment (PPE).
• Must be able to identify different colors for work purposes. In Illumina, we handle components/chemicals with different colors, and it is necessary to be able to differentiate and identify the correct components/chemicals (using visual) during operation.
• Proficient with basic weighing and pipetting skill.
• Familiar with basic laboratory procedures. Relevant experience with laboratory testing, QC of molecular-biology-based assays will be an advantage.
• Possess a positive attitude and sense of urgency.
• Meticulous, keen attention to details and organized.
• Good analytical skills.
• The candidate must be able to work 12 hours (from 0800 to 2015 for the day shift and from 2000 to 0815 for the night shift) rotating shifts with staggered break times in accordance with the roster.
• Team player and possess effective interpersonal and communication skills.
• Able to lift 15kg or less of heavy weight safely.

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and
responsibilities.


Preferred Experience/Education/Skills:


• Diploma in Science (preferably Chemistry or Biology), Chemical Process Technology or related Life Science or Technology with more than 3 years of working experience.
• NTC/NITEC/ Secondary School / ‘O’ Level or equivalent with more than 5 years working experience will also be considered.
• Minimum 1 year of hands-on experience in handling laboratory analytical instruments, such as Ultra/High Performance Liquid Chromatography (U/HPLC), Ion Chromatography (ICS), UV/Vis Spectrophotometer (SpectraMaxTM, NanodropTM) or liquid chromatography-mass spectrometry.
• Hands on experience in sample preparation using basic laboratory equipment such as micropipettes, incubator and mini-centrifuge; Chromatogram analysis for liquid samples preferred.
• Hands-on experience and good micro-pipetting skills/techniques using Single channel and/or Multichannel micro-pipettes, including reverse pipetting technique preferred.
• Knowledge in handling and preparation of reagents (including enzymes or proteins) preferred.
• Experience in ISO 13485, MDSAP, and GMP controlled manufacturing/production environment preferred.
• Good understanding of GDP and cGMP, knowledge of ISO and MDSAP requirements preferred.
• QC experience in a manufacturing environment preferred.
• Relevant experience in a manufacturing environment working with standard production control tools – LIMS, MES, ERP, inventory control, work orders preferred.
• At least 1-2 years of training experience or Train-The-Trainer certification preferred.


Tell employers what skills you have

Troubleshooting
GMP
Investigation
Chemistry
Biology
Attention to Details
Reagent
Laboratory
Manufacturing
Analytical Instruments

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