QC Analyst 3

<p><span style="text-decoration: underline;"><strong>Position Summary</strong></span><br>The QC Analyst 3 will support various duties within the Quality Control (QC) department. This position plays a key role in ensuring the technical operations of QC, focusing on the technical suitability of bioanalytical test methods rather than day-to-day product testing. The role includes responsibility for the analytical method lifecycle, including method transfer, validation, compendial verification, performance monitoring, and continuous improvement, as well as ensuring analytical equipment is installed and qualified. The QC Analyst will support ProKidney’s pipeline, from Phase III clinical development through commercial operations.</p> <p><span style="text-decoration: underline;"><strong>Responsibilities</strong></span></p> <p>• Writes and executes procedures for analytical method protocols, generating reports related to QC method transfer, validation, and verification.<br>• May write standard operating procedures (SOPs), protocols, and/or participate in instrument qualifications and analytical system validation.<br>• Support monitoring of analytical method performance, including assessment of analytical method system suitability requirements.<br>• Assist with data trending and aid in compilation of trend reports utilizing statistical tools.<br>• Work with internal departments to ensure system lifecycle document readiness and support analytical instrument qualification and system validation.<br>• Present to cross-functional teams and effectively communicate critical analytical issues and solutions.<br>• Familiarity with FDA and EMA guidance documents relevant to cell therapy, and compendial methods from USP and EP.<br>• Working knowledge of quality systems requirements.<br>• Ability to work in a fast-paced, collaborative environment, managing workload based on changing priorities.<br>• Demonstrated leadership skills and the ability to collaborate with and effectively influence others.<br>• Establish, revise, review, perform gap-assessment, and maintain procedures (including protocols and technical reports).<br>• Assure laboratory procedures are compliant with current requirements and facilitate updates as needed.<br>• Complete documentation in accordance with current Good Manufacturing Practices (cGMP).<br>• Maintain QC lab and related systems to ensure compliance with industry standards and inspection readiness.<br>• Support CAPA’s, deviations, investigations, and OOS’s, ensuring effective resolution and continuous improvement.<br>• Other tasks as assigned.</p> <p><span style="text-decoration: underline;"><strong>Qualifications</strong></span></p> <p>• Bachelor’s degree or equivalent in Chemistry/Biochemist