Temporary Senior Quality Assurance Auditor

North Carolina State University, United States

Updated: about 2 months ago
Deadline: ;

Posting Details
Position Information


Posting Number PG194500TM
Position Number 11ASO3314
Position Type Temporary
Essential Job Duties
Reporting to the National Quality Assurance Unit Manager, the incumbent is a senior member of the IR-4 Project Quality Assurance Unit and will be responsible to perform, and train others to perform, various types of quality assurance audits to ensure the quality and integrity of the IR-4 Project submissions to the United States Environmental Protection Agency (US EPA). Many of the functions of this position are required for the IR-4 Project to achieve compliance with US EPA Federal Good Laboratory Practice Regulations (GLPs – as documented in Chapter 40- Code of Federal Regulations, Part 160). The duties include but are not limited to:
1. Data and Documentation Review and Analysis (70%)
  • Analytical Data, Analytical Summary Reports, and Contributing Scientists Reports
    • Critically review data and reports from analytical laboratories for compliance with GLP regulations.
    • Issue an audit report to required individuals (Study Director, Management, etc.) reporting any findings deemed as not in compliance with the GLPs and review responses to audit findings.
    • Issue a GLP Compliance Statement for inclusion in the final Analytical Summary or Contributing Science Report.

  • Final Study Reports
    • Perform audits of draft IR-4 study reports prior to submission to EPA. This will include comparing the Study Report with the raw data to ensure that the Study Report is an accurate reflection of the raw data in the study files.
    • Issue an audit report to Study Director and Management noting any findings of non-compliance and review the responses to determine if issues have been adequately addressed.
    • Issue a Statement of Compliance for inclusion in the Final Study Report.
  • Field Data Books
    • Critically review field data books (eFDB) for compliance with the GLP regulations.
    • Issue an audit report of any non-compliance issues and review response to ensure they are adequately addressed

2. Utilize electronic systems and SOPs (10%):
  • Independently utilize an electronic QA system, in particular eQA, for audits and Standard Operating Procedure (SOP) training.
  • Independently utilize the IR-4 electronic field notebook system (eFDB).
  • Independently review IR-4 SOPs and be able to identify areas needing revision.


3. Process Assessment (10%)
  • Perform periodical inspections of IR-4 Headquarters and Quality Assurance Unit Standard Operating Procedures (SOPs) to ensure that they are following approved procedures in day to day functions. Specifically conduct reviews of existing SOPs and identify areas needing revision as well as recommending the drafting of SOPs that are needed. This function will require creativity, innovation, organization, adherence to GLP requirements and team work to coordinate any proposed changes or additions to the SOPs with other personnel affected by said changes.

4. Facilitate information exchange and training quality assurance auditors (10%):
  • Develop materials for use in fostering communication of IR-4 practices and standards among QA units across the United States, and contracted QA auditors, to gain the highest degree of consistency in QA functions Product Disposition.
  • Assist National Quality Assurance Manager in the development of training programs for the national IR-4 Program (field and lab researchers, and regional and HQ staff).
  • Provide instruction and mentoring of new and mid-level quality assurance auditors on reviewing and auditing analytical data, analytical summary reports, contributing scientist reports, final reports, and field data books.
  • Provide instruction and training for field and lab researchers as well as regional and HQ staff on the eQA system, and on reviewing IR-4 SOPs.

Other duties as assigned by the National Quality Assurance Unit Manager.
Is Time Limited No
If Yes, Appointment Length

Department Information


Job City & State Various
Department IR-4 Project

System Information


Classification Title Temporary-Technical/Paraprofessional
Working Title Temporary Senior Quality Assurance Auditor

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