Job Title: Compliance QA Specialist - GxP QualityJob Description The Compliance QA Specialist will play a crucial... role in supporting GxP inspection and audit activities within the inspection readiness program. This includes audit...
, as needed. As applicable per designated PSC business, maintain GxP and financial audit inspection readiness. Utilize experience and expertise... under pressure to meet specific deadlines. Dedication to quality and reliability in all work tasks. Excellent verbal and written...
. Demonstrated knowledge of GxP Health Authority Regulations and Quality Systems. Knowledge of biologics and chemical processes... vendor management program. Develops and maintains the approved vendor list, applies quality risk management (QRM) and phase...
. Maintain traceable documentation to support GXP activities. Potential opportunity to manage clinical projects. Partner... with key stakeholders including Quality Assurance and Regulatory Affairs to ensure supplies are labeled and released...
timely delivery of high-quality Microsoft 365 applications. Coordinate with vendors and service providers to support..., business, and IT teams to support effective execution and issue resolution. Operational Excellence, Quality & Compliance...
risks. Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality, for Exelixis business... across the GxP landscape that identifies and manages issues and risks while driving continuous improvement to ensure continuous...
performance. Establish and enforce data governance policies, data quality standards, security protocols, and compliance... frameworks (e.g., FAIR, GxP, HIPAA, IAM, Data Mesh). Implement and manage AWS Lake Formation and Databricks Unity Catalog...
., GxP, HIPAA, GDPR) and internal quality and security standards. Ensure that all product releases meet rigorous quality... objectives. Partner with engineering, architecture, and quality assurance teams to ensure timely delivery of secure, scalable...