Reagent Qc Technician 3

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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:

- Participate and guide others in process improvement to enhance manufacturing/QC process capabilities in area such as quality and efficiency.
- Assist and guide others in non-production activities such as engineering studies, NCR investigation runs, validation / PPQ runs.
- Involve in work instruction review under some guidance.
- Incident investigation and reporting
- Participate in incident investigation and be able to provide a summary report under direct guidance.
- Able to organize the objectives and structure of the report, drafting and proofreading to improve the report under some guidance.
- Report abnormalities and support investigation of nonconforming material under some guidance.
- Learning and Development
- 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 (