Reagent QC Technician 4

Position Summary:

Reagent QC Technician 4 (RQCT 4) 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 4 is also required to lead simple incident investigation and support engineering study under some supervision. RQCT 4 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, guide and be accountable for others on daily QC routine tasks (e.g. QC sample collection) within the shift.

• Conduct, guide and be accountbale for others on analytical, molecular and biochemical analysis for intermediate and final products (reagent samples) within the shift.

• Prepare, guide and be accountable for others on reagent samples using basic laboratory equipment in accordance with Work Instruction (WI) within the shift.

• Able to test. guide and be accountable for others on preparing reagent samples using different laboratory analytical instruments in accordance with Work Instruction (WI) within the shift.

• 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, guide and be accountable for others on regular maintenance / inspection of measuring devices and equipment for accuracy within the shift.

• Perform, guide and be accountable for others on peer verification to ensure test / inspection process follow Work Instruction within the shift.

• Perform, guide and be accountable for 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 and be accountable for others on the preparation, qualification and tracking of oligos and standards to ensure sufficient and non-expired inventory for sample analysis.

• Prepare, guide and be accountable for others on chemical stock solutions and reagents for analysis.

• Guide and be accountable for others to verify inventory records of all control and consumable are updated.

• Guide and be accountable for others in procurement, purchasing duties according to inventory records.

• Accountable for the training progress of new technicians on QC testing processes defined in work instruction(s) within the shift.

• Improvement work:
oParticipate, guide and be accountable for others in process improvement within shift to enhance manufacturing/QC process capabilities in area such as quality and efficiency.
oAssist, guide and be accountable for others in non-production activities such as engineering studies, NCR investigation runs, validation / PPQ runs within the shift.
oInvolve in work instruction review under broad guidance.

•Incident investigation and reporting
oParticipate in incident investigation and be able to provide a summary report under some guidance.
oAble to organize the objectives and structure of the report, drafting and proofreading to improve the report under broad guidance.
oReport abnormalities and support investigation of nonconforming material under broad guidance.

•Learning and Development
oProvide feedback on competency-based assessment and workplace learning techniques.
oResponsible for the certification rate of the assigned process.

•Be a role model for Reagent QC Technician 1-3.

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 4 years of working experience.

•NTC/NITEC/ Secondary School / 'O' Level or equivalent with more than 7 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.

•Good knowledge of molecular biology eg library preparation and NGS (Next Generation Sequencing)

•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.

•At least 1-2 years of experience as a team/line leader is a plus.