Senior Quality Assurance Auditor, QMS SmartSolve
Descripción del trabajo
Must reside in the United States (USA)
The Sr. QA Auditor position will maintain and enhance the Document/Records Control and Training Program. This includes managing work within the electronic quality management system (SmartSolve) and providing quality management systems support. This position is heavily task-oriented toward document processing and activities may impact project timelines. Responsible for the enhancement and support of the SmartSolve Quality Management System (QMS) and certification to ISO 9001, ISO 27001, SOC 2, and HIPPA. Supporting and participating in client initiated quality audits against the SmartSolve product and services used by 150+ life science companies (pharma, medtech, labs). This position is US based to support and lead the in-person engagement requirements for client auditors.
Assume the role of system owner and administrator of the electronic quality management system (SmartSolve).
Support the development and implementation of additional electronic Quality System modules when requested.
Initiate system and process enhancements to ensure department efficiency and customer satisfaction.
Maintain SmartSolve Internal Apps system and establish a tracking and reporting system for quality and business related inputs and outputs
Maintain and develop the controlled document master list, quality system records logs, reports, and other tracking tools as needed
Coordinate efforts for the development and implementation of new and updated Quality System procedures. Process requests for document changes
Ensure that all procedures are reviewed and updated at least annually per internal requirements
Achieve technical and stylistic consistency in written quality documents to prevent contradicting information
Create and maintain employee training plans and records
Maintain training metrics and produce training compliance reports
Assist with employee orientation and QMS training
Quality Management System
Assist in the preparation of CAPA plans and implementation of correction, corrective action and preventive actions
Assist in preparing Management Review Presentations, hand-outs, and supporting documentation
Support other department system activities, including trend analysis, CAPA verification and internal audit schedule implementation and coordination
Other Duties as Assigned
Other tasks related to the department, such as special projects or research, will be completed as assigned
Bachelor's Degree Preferred
5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance, or Equivalent combination of education, training and experience.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
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