Quality Engineer Consultant
CurrentResponsible for daily project coordination and organization, providing leadership and mentorship to professionals, and delivering tailored Quality solutions to clients with unique needs.Offer guidance on Quality Systems, Change Management, Investigations, and Process Improvement initiatives. Provide feedback on Quality impacting deliverables.Lead site-specific CSV activities for computer system integration projects, collaborating with global teams. Coordinate routine CSV… Show more Responsible for daily project coordination and organization, providing leadership and mentorship to professionals, and delivering tailored Quality solutions to clients with unique needs.Offer guidance on Quality Systems, Change Management, Investigations, and Process Improvement initiatives. Provide feedback on Quality impacting deliverables.Lead site-specific CSV activities for computer system integration projects, collaborating with global teams. Coordinate routine CSV lifecycle activities, ensuring compliance with company procedures and regulations. Author, review, and approve applicable CSV documentation. Oversee test script execution and defect management. Assist in developing requirements for computerized systems in GxP operations. Support health authority inspections as a Subject Matter Expert for CSV lifecycle activities.Support day-to-day planning and scheduling for Facilities and Calibration Team. Process, track, review, and trend GxP maintenance and calibration work orders through CMMS. Create preventative maintenance and calibration procedures for GxP equipment. Collaborate cross-functionally to schedule activities. Initiate supplier qualification process for new vendors in Supplier Quality Management. Assist in vendor qualification approval cycle in Veeva. Track parts and inventory needs for critical spares. Create a spare parts database in CMMS. Author Environmental Health and Safety procedures for vendor qualification and training before on-site service. Show less