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Quality Assurance Auditor I

Quality Assurance Auditor I

ID 
2017-1332
Job Location 
US-NC-Chapel Hill
Type 
Regular Full-Time

More information about this job

Overview

The Quality Auditor I will provide technical support in the evaluation of Rho processes, procedures and trial conduct to ensure compliance with regulatory requirements and ICH GCP principles. This individual will act as a QA professional in providing quality assurance-related solutions to both internal and external customers. The QA Auditor will also be responsible for building and maintaining effective working relationships throughout Rho.

Responsibilities

  • Maintaining working knowledge of regulatory requirements, ICH GCP principles, and clinical trial processes
  • Preparing audit plans for individual audits
  • Assisting with audit activities including sponsor audits, clinical site audits, key document audits, database audits, trial master file audits, and software and system validation documentation audits
  • Supporting audits of clinical trial vendors providing services such as central imaging, central laboratory services, ECG reading, IP management and distribution, IRB review, and EDC systems
  • Evaluating internal compliance with company procedures, policies, programs, initiatives, GCP, and applicable regulations (internal system and process audits)
  • Clearly communicating and reporting (verbally and in writing) audit outcomes and escalating significant compliance concerns to project teams, QA staff, Rho management, and sponsor contacts appropriately
  • Assisting in the preparation for, coordination, documentation, and follow-up of regulatory inspections
  • Assisting in the creation, review, revision, and management of procedural documents
  • Providing ad hoc regulatory compliance guidance and quality improvement consult to internal and external customers
  • Reporting, managing, and following deviations, complaints, issues, non-conformances, and their related CAPAs.

Qualifications

  • BA/BS in life sciences, social sciences, or a related degree; and at least 4 years of experience actively supporting clinical research.
  • Must be a team player with integrity, a commitment to quality, and the ability to think critically and creatively.
  • Ability to demonstrate strong verbal and written communication skills as well as the ability to understand and coordinate multiple projects.
  • Ability to prioritize, be organized and detail-oriented, and demonstrate strong analytical skills.
  • The successful candidate will possess a working knowledge of and experience with GCP.
  • Ability to maintain high level of accuracy and attention to detail.
  • Must exhibit professionalism.
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment.
  • Good analytical and organizational skills.
  • Ability to make a decision in a timely manner.
  • Independently motivated, detail oriented and good problem solving ability.
  • 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 preferred.
  • This position is based in Chapel Hill, NC.

EOE. Veterans/Disabled