Data integrity Specialist

Job Description: Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+ principles and regulatory standards (21 CFR Part 11, Annex 11). Review audit trails, monitor user access, and perform periodic data reviews. Lead and coordinate Out-of-Specification (OOS) investigations (Phase I & II), including root cause analysis, hypothesis testing, and CAPA implementation. Perform titration-based content uniformity tests as per SOPs and pharma

Job Description Job Description: The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, includes a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile, which is currently in the operational start-up phase. FLEx Sterile is positioned to play a pivotal role in delivering our clinical pipeline to patients worldwide, supporting a diverse range of product modalities including sterile small molecules, biologics, vaccines

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse Job Description Data Integrity Compliance Lead Divisi

Job Description Join our Internal Audit Chief Data Office and help shape the future of data risk management at JPMC. You will play a pivotal role in safeguarding our information assets and driving continuous improvement in data governance. This is your opportunity to make a meaningful impact in a dynamic, collaborative environment. As a Vice President, Data Risk Management and Governance, you will support and execute the department's data risk strategy, ensuring robust governance and regulator