Qa Auditor 1 (Wfh/Remote)

The QA Auditor 1 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.

Key Responsibilities:

System Administration

• Initiate system and process enhancements to ensure department efficiency and customer satisfaction.
• Support the development and implementation of additional electronic Quality System modules when requested.
• Maintain SmartSolve Internal Apps system and establish a tracking and reporting system for quality and business-related inputs and outputs
• Assume the role of system owner and administrator of the electronic quality management system (SmartSolve).

Document Management

• Ensure that all procedures are reviewed and updated at least annually per internal requirements
• Coordinate efforts for the development and implementation of new and updated Quality System procedures. Process requests for document changes
• Maintain and develop the controlled document master list, quality system records logs, reports, and other tracking tools as needed

Achieve technical and stylistic consistency in written quality documents to prevent contradicting information

Training Management

• Create and maintain employee training plans and records
• Assist with employee orientation and QMS training
• Maintain training metrics and produce training compliance reports

Quality Management System

• Assist in preparing Management Review Presentations, hand-outs, and supporting documentation
• Assist in the preparation of CAPA plans and implementation of correction, corrective action and preventive actions
• 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

Minimum Experience Requirements

• Familiar with Application Development Life Cycle and Software Engineering Methodologies
• Two years of experience with SmartSolve suite of products
• One to three years of experience or a combination of education and experience in business applications related to quality management or related enterprise business management application.
• Familiarity with ISO and/or GxPs

Skill Requirements

• Familiarity with Quality Assurance and Quality Management Systems
• Excellent ability to work in a team environment and display a positive, can-do attitude
• Ability to communicate with both technical and non-technical personnel
• Strong analytical, testing, and problem-solving skills
• Must work well independently
• Must have initiative, judgment, and ability to manage multiple tasks with frequent interruptions with high attention to detail and accuracy
• Strong verbal and written communication skills in English

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