Quality Assurance Specialist Ii
Current• Conduct daily walkthroughs of Manufacturing areas to monitor, processes, and controls, ensuring that performance and quality of products conform to established standards and agency guidelines.• Assist with continuous improvement by providing quality feedback on GxP and documentation behaviors to our cross-functional partners.• You will prioritize accurate, and complete execution of GMP documentation review to support product disposition.• Support our cross-functional teams (i.e., MFG, FAC, ENG..) to help resolve routine or non-routine compliance concerns as well support Manufacturing processes that requires QA presence on the floor. Support other tasks (e.g. audits , deviations, change controls, and CAPA• Perform reconciliation and archiving of GMP documentation according to procedures.• Perform Quality transactions within the SAP ERP, LIMs, and Trackwise Systems.Maintain compliance with all required training on department specific procedures.• Participate in Quality Gemba walk throughs of the Manufacturing Floor and address concerns, as applicable.• Approve protocols and revised or created GMP documents.
