Reagent QC, Technician 1 - Singapur, Singapore - Illumina

Illumina Singapur, Singapore

1 week ago

Full time

Description

What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Reagent QC Technician 1 (RQCT 1) 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 1 is also required to assist in incident investigation and engineering study.

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 requirement, 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 daily QC routine tasks (e.g. QC sample collection) under broad guidance

Conduct analytical, molecular and biochemical analysis for intermediate and final products (reagent samples) under broad guidance

Prepare reagent samples using basic laboratory equipment in accordance with Work Instruction (WI) under broad guidance

Able to test prepared reagent samples using different laboratory analytical instruments in accordance with Work Instruction (WI) under broad guidance

Generate and analyze test results (example: Chromatogram) in accordance with Work Instruction (WI) under broad guidance

Ensure accurate data generation and entry of records into Manufacturing Execution System (MES) or Laboratory Information Management System (LIMS) under broad guidance

Perform regular maintenance / inspection of measuring devices and equipment for accuracy under broad guidance

Perform peer verification to ensure test / inspection process follow Work Instruction (WI) under broad guidance

Perform basic troubleshooting of common issues and investigation of reagent sample failure (Out of Specification) to determine the root cause and perform immediate corrective actions with some supervision

Prepare, qualify and track oligos and standards to ensure sufficient and non-expired inventory for sample analysis under broad guidance

Prepare chemical stock solutions and reagents for analysis under broad guidance

Ensure inventory records of all control and consumable are updated under broad guidance

Responsible in procurement, purchasing duties according to inventory records under broad guidance

Partner with new technician on QC testing processes defined in work instruction(s)

Improvement work:Participate in process improvement to enhance manufacturing/QC process capabilities in area such as quality and efficiency under broad guidanceAssist in non-production activities such as engineering studies, NCR investigation runs, validation / PPQ runs under broad guidance

Participate in incident investigation

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:

Good understanding of GDP and cGMP, knowledge of ISO and MDSAP requirements preferred

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:

Fresh graduate with Diploma in Science (preferably Chemistry or Biology), Chemical Process Technology or related Life Science or Technology.

Minimum 1 years of operations experience for Secondary School / 'O' Level / NTC / NITEC/ Diploma / Non-Science or Non-Engineering Degree or equivalent.

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

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

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

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