|About the Department
||The IR-4 Project is a national Federal/State partnership research program to assist farmers of fruits, vegetables, nuts, herbs, ornamentals and other specialty crops by facilitating registration of safe and effective chemical and bio-based pest management products. The IR-4 Project is needed because the crop protection industry focuses their research efforts on major crops such as corn, soybean and cotton that provide the companies adequate return on their development investment.
Without IR-4, farmers of specialty crops would only have access to a few crop protection products to protect their crops. IR-4 Project Headquarters provides national leadership, coordination and regulatory compliance for the IR-4 Project research activities performed by approx. 125 scientists at over 20 public sector research farms and five analytical laboratories throughout the United States.
|Essential Job Duties
||Reporting to the National Quality Assurance Unit Manager and a member of the IR-4 Project Quality Assurance Unit, this position is responsible to perform various types of quality assurance audits of IR-4 Project generated raw data and reports to assist in ensuring the quality and integrity of 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).
Duties include, but are not limited to:
Data and Documentation Review and Analysis (80%):
- Final Study Reports:
- Following the Federal GLP requirements perform mandatory audits of draft IR-4 study reports prior to submission to EPA. Compare 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.
- Review response from Study Director and Management to determine if audit findings were adequately addressed.
- Issue a Statement of Compliance for inclusion in the Final Study Report.
- Field Data Books-Review assigned field data books:
- Critically reviewing book for accuracy of raw data, a summary of which will be entered in reports for compliance with GLP.
- Develop and issue an audit report to Study Director, Testing Facility Management and the Field Research Director of any non-compliance issues and seek response.
- Review response from Study Director and Field Research Director to determine if audit findings were adequately addressed.
- Contributing Scientists Reports-As assigned, review Contributing Science Reports from analytical laboratories, seed treatment facilities and food processing laboratories:
- Critically reviewing Contributing Science Report for compliance with GLP, checking for non-compliance issues.
- Issue an audit report to Study Director and Testing Facility Management reporting any issues deemed as not in compliance with the GLPs.
- Review responses to audit findings.
- Issue a GLP Compliance Statement for inclusion in the final Contributing Science Report.
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 GLPrequirements and team work to coordinate any proposed changes or additions to the SOPs with other personnel affected by said changes.
Facilitating information exchange and cultivating partnerships/Training (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.
The position will also perform other duties as assigned by the National Quality Assurance Unit Manager and must be willing to travel to conduct audits and attend major IR-4 meetings throughout the United States.