Job Description
- 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
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