Audit Operational Specialist
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Job Description
Quality Assurance Specialist II at ICON contributing to clinical research by ensuring quality and compliance. Collaborating with cross-functional teams to meet client needs and streamline processes.
Responsibilities:
- Contribute to quality assurance and compliance activities, taking responsibility for your deliverables and working collaboratively
- Embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
- Perform Quality Management Review (QMR) on active projects
- Extract and review study data from the SQL database to ensure accuracy according to system specifications and client requirements
- Communicate with department management and project managers regarding quality and/or compliance issues and trends
- Conduct accurate and timely secondary review of QMRs
- Act as subject matter expert for compliance staff in specialized tasks
Requirements:
- Bachelor's degree in a related field (e.g., Life Sciences, Regulatory Affairs, or Compliance)
- Relevant experience in compliance, quality management, or a related field within the Interactive Technologies division
- Proficiency in performing Quality Management Reviews (QMR) on active projects, ensuring adherence to established quality standards and procedures
- Strong communication skills to effectively convey quality and compliance issues and trends to department management and project managers
- Perform accurate and timely secondary reviews of QMRs, identifying discrepancies and recommending corrective actions
- Act as a subject matter expert for compliance staff, providing guidance and support in specialized compliance tasks
- Collaborate effectively with cross-functional teams and colleagues to ensure compliance goals are met
- Willingness to travel as required (approximately 10%)
Benefits:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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