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Senior/Principal Quality Assurance Auditor

Senior/Principal Quality Assurance Auditor

ID 
2017-1310
Job Location 
US-NC-Chapel Hill
Type 
Regular Full-Time

More information about this job

Overview

The Senior/Principal QA Auditor will provide technical expertise to Rho’s Quality Assurance function. This individual will act as an independently functioning QA professional in providing quality assurance-related solutions to both internal and external customers. The Senior/Principal QA Auditor will also be responsible for building and maintaining effective working relationships throughout Rho and for mentoring QA teammates.

Responsibilities

  • Maintaining significant knowledge in regulatory requirements and ICH GCP principles.
  • Preparing audit plans for individual audits and audit/risk mitigation plans for larger projects and programs, as needed.
  • Leading and/or assisting with audit activities including sponsor audits, clinical site audits, key document audits and software and system validation documentation audits.
  • Conducting audits of clinical trial vendors providing services such as central imaging, central laboratory services, ECG, IP management and distribution, IRB review, and EDC, as required.
  • Evaluating internal compliance with company procedures, policies, programs, initiatives, GCP, and applicable regulations.
  • Assisting the organization in preparation for, coordination, hosting, conduct, documentation and follow-up of regulatory inspections.
  • Using a risk-based approach in the identification of audit candidates and the evaluation of personnel, facilities, documents, processes and systems.
  • Assisting in the creation, review, revision and management of procedural documents.
  • Clearly communicating and reporting (verbally and in writing) audit outcomes and escalating significant compliance concerns to project teams, QA and Rho management and sponsor contacts appropriately.
  • Providing regulatory compliance guidance and quality improvement consult to internal and external customers.
  • Employing risk identification and mitigation strategies related to identified and potential compliance issues.
  • Reporting, managing and following deviations, complaints, issues, non-conformances and their related CAPAs.
  • Assisting in the management of contract auditors.
  • Modeling Rho’s Core Values.
  • Supporting business proposal preparation and defense.
  • Preparing training materials and conducting training related to relevant QA topics.

Qualifications

  • BA/BS in life sciences, social sciences or a related degree.
  • 8 years in the biotechnology, medical device or pharmaceutical industries.
  • At least 4-6 years of increasingly responsible experience in clinical (GCP) quality assurance.
  • Certification in auditing, clinical research, or regulatory affairs (RQAP, CCRP, RAC, etc.) preferred.
  • The successful candidate will be a team player with integrity, a commitment to quality, and the ability to think critically and creatively.
  • Candidate must possess strong verbal and written communication skills.
  • Candidate must be able to prioritize, be organized and detail-oriented and demonstrate strong analytical skills.
  • Candidate must possess strong Excel, Word, and PowerPoint skills.
  • The candidate must be able to work independently and as a member of a team.
  • Prior QA experience supporting professional services within the biotechnology or pharmaceutical industries is required.
  • This position is based in Chapel Hill, NC.

 

EOE. Veterans/Disabled