Lead Research Qa Specialist

urmc.rochester.edu

Rochester, New York, United States of America
$41.58 - $62.37 ph
**
Quality assurance in gcp
Electronic quality management systems
Document control and database applications
** The University of Rochester is seeking a Lead Research QA Specialist to oversee Quality Assurance functions within their Clinical and Translational Science Institute. The ideal candidate will have a strong background in Good Clinical Practice and quality management systems, with a focus on compliance and continuous improvement. **

Job Summary

  • Establishes, manages, and provides oversight of Quality Assurance functions within the CHeT QA team, partnering with stakeholders to lead quality initiatives.
  • Facilitates and manages the Quality Management Systems (QMS) program, leads compliance audits and regulatory inspections, and supports continuous improvement of the QMS.
  • Provides expertise, training, and advice on clinical trial industry best practices, governmental regulations, ICH Guidelines, and other relevant quality compliance requirements.

Matching Summary

Match Score: 75

** The University of Rochester is seeking a Lead Research QA Specialist to oversee Quality Assurance functions within their Clinical and Translational Science Institute. The ideal candidate will have a strong background in Good Clinical Practice and quality management systems, with a focus on compliance and continuous improvement. **

Salary

$41.58 - $62.37

Skills & Requirements

Must-have

  • Quality Assurance in GCP
  • Electronic Quality Management Systems
  • Document Control and Database Applications
  • Risk-based Monitoring and Plans
  • Regulatory Inspections and Audits

Nice-to-have

  • Continuous Improvement of QMS
  • Strategic Audit Plan Development
  • Expertise in Clinical Trial Best Practices
  • Mentoring Clinical Project Managers
  • Fostering Inclusive Culture

Key Requirements

  • Bachelor’s degree required
  • Master’s degree preferred
  • 10 years of relevant experience required
  • Quality Assurance Audit Certification upon hire preferred

Work Rights

Not specified

Tailored Resume

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