Senior Auditor, Audits and Inspections Program
Job Description:
• Champions and adheres to Worldwide’s Quality Management System (QMS)
• Serves as a positive ambassador of the QA organization with internal and external customers
• Develops and executes personal and QA goals and objectives
• Performs QA audits for Vendors, Internal Process, Clinical Investigator, Document and other audits, as assigned
• Ensures quality deliverables, on time, and in compliance with regulations and Worldwide processes
• Oversees, monitors and reports on QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvements
• Oversees the maintenance and archiving of records for each audit
• Participates in the driving continuous process improvement
• Provides support to Sponsors Audits and Inspections in relation to Worldwide provided services
Requirements:
• M.S. in a scientific or allied health field and 5+ years of relevant GCP, GcLP, GLP, GVP, and/or GPP experience
• Excellent understanding of the Drug Development Process
• Minimum 3 years of Quality Assurance auditing experience
• IT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, Trackwise, SharePoint, and PowerPoint
Benefits:
• Flexible work arrangements
• Professional development opportunities
Apply tot his job
Apply To this Job
• Champions and adheres to Worldwide’s Quality Management System (QMS)
• Serves as a positive ambassador of the QA organization with internal and external customers
• Develops and executes personal and QA goals and objectives
• Performs QA audits for Vendors, Internal Process, Clinical Investigator, Document and other audits, as assigned
• Ensures quality deliverables, on time, and in compliance with regulations and Worldwide processes
• Oversees, monitors and reports on QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvements
• Oversees the maintenance and archiving of records for each audit
• Participates in the driving continuous process improvement
• Provides support to Sponsors Audits and Inspections in relation to Worldwide provided services
Requirements:
• M.S. in a scientific or allied health field and 5+ years of relevant GCP, GcLP, GLP, GVP, and/or GPP experience
• Excellent understanding of the Drug Development Process
• Minimum 3 years of Quality Assurance auditing experience
• IT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, Trackwise, SharePoint, and PowerPoint
Benefits:
• Flexible work arrangements
• Professional development opportunities
Apply tot his job
Apply To this Job