Reagent Qc, Technician 1

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 guidance
- Assist 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
- Team player a