Job Description
<b>Job Description Summary</b>The QC Sample Management Technician reporting to the QC Supervisor - Sample Management will support lab operations by performing routine sample management to support Quality Control (QC) Analytical laboratories<br> <b>Job Description</b><b>Major accountabilities: </b><b>Position Summary</b><ul><li>Support lab operations by performing routine QC in-process and release test sample and QC retain sample management to support Quality Control (QC) Analytical laboratories.</li></ul><b>Core Responsibilities</b><ul><li>QC sample / retains sample handling including receival, registration, storage, distribution and destruction</li><li>Delivering samples to QC laboratories for testing as required</li><li>Preparation of samples for shipment</li><li>Performing sample inventory and disposal</li><li>Ensure samples and materials are appropriately labelled and maintain sample tracking, labelling and chain of custody records in accordance with regulatory requirements and written procedures.</li><li>Maintain the Sample Retain inventory room, refrigerators, and freezers.</li><li>Ensure that Sample Retains are stored in appropriate locations.</li><li>Ensures adequate storage areas are available in each sample storage area.</li><li>Ensure Sample Retains are readily available for Shipping with proper documentation. Prepare for shipping testing to contract labs for chemistry and microbiology samples.</li><li>Dispose of Sample Retains in accordance with cGMP regulations after retention time has passed.</li><li>Organize Sample Retains by lot/batch number, documenting the storage location in logbooks/excel for ease of retrieval.</li><li>Performs other related duties as assigned.</li></ul><b>Continuous Improvement</b><ul><li>Drive a culture of continuous improvement and proactively identify opportunities for efficiency enhancements and process improvements within the Quality Control procedures.</li></ul><b>Collaboration</b><ul><li>Interacting with outside customers and functional peer groups</li><li>Communicate effectively with management regarding task completion, roadblocks, and needs.</li><li>Support investigation of sample management-related issues: Work together with QA and <span>Investigation/Compliance</span> personnel and with stakeholders on addressing any non-compliance or sample management-related deviations, implementing corrective actions, and documenting findings.</li></ul><b>Key Performance Indicators</b><ul><li>Timely delivery on commitments with and departmental KPIs</li><li>Timely responses and solutions to training-related issues</li><li>Efficient and flexible usage of the available resources</li><li>Compliance to all relevant company policies and guidelines</li><li>Exhibiting core Novartis values and behaviors and fostering these within the team</li></ul><b>Ideal Background</b><b><span>Education</span></b><span>:</span><ul><li>HS diploma, Associate's degree, Biotechnology certificate, or Bachelor's degree in biology, chemistry, or other related degree concentration</li></ul><b><span>Languages:</span></b><ul><li>English</li></ul><b><span>Experience:</span></b><ul><li>0-2 years of experience in a cGMP environment / commercial manufacturing.</li><li>Experience in a regulated GMP environment, preferably within QC operations in a cell therapy company.</li></ul><b><span>Skills:</span></b><ul><li>Experience with handling Liquid Nitrogen (LN2) samples</li><li>Experience with use and routine maintenance of sample handing equipment including BSCs, refrigerators, freezers and LN2 storage tanks.</li><li>Experience with pipetting and aliquoting</li><li>Experience with electronic laboratory management systems (such as LIMS)</li></ul><b>Competency Profile:</b><ul><li>Strong communication skills for interacting with a variety of collaborators and partner gr