Position Summary:
Reagent QC Technician 2 (RQCT 2) 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 2 is also required to assist in incident investigation and engineering study. RQCT 2 is also required to assist in the training of new employees.
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)
•Conduct analytical, molecular and biochemical analysis for intermediate and final products (reagent samples)
•Prepare reagent samples using basic laboratory equipment in accordance with Work Instruction (WI)
•Able to test prepared 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)
•Ensure accurate data generation and entry of records into Manufacturing Execution System (MES) or Laboratory Information Management System (LIMS)
•Perform regular maintenance / inspection of measuring devices and equipment for accuracy
•Perform peer verification to ensure test / inspection process follow Work Instruction (WI)
•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 under broad supervision
•Prepare, qualify and track oligos and standards to ensure sufficient and non-expired inventory for sample analysis
•Prepare chemical stock solutions and reagents for analysis
•Ensure inventory records of all control and consumable are updated
•Responsible in procurement, purchasing duties according to inventory records
•Assist in training new technician on QC testing processes defined in work instruction(s)
•Improvement work:
oParticipate in process improvement to enhance manufacturing/QC process capabilities in area such as quality and efficiency
o Assist in non-production activities such as engineering studies, NCR investigation runs, validation / PPQ runs
o Involve in work instruction review under direct guidance
o Participate in incident investigation
•Incident investigation and reporting
o Participate in incident investigation
o Able to organize the objectives and structure of the report, drafting and proofreading to improve the report under direct guidance
o Report abnormalities and support investigation of nonconforming material under direct guidance
•Learning and Development
o Coordinate training and assessment activities
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Be a role model for Reagent QC Technician 1
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.
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.
