Job description
Posting Information
Posting Number
PG192207EP
Internal Recruitment
No
Working Title
Quality Assurance Auditor
Anticipated Hiring Range
Commensurate with experience ($60,000 - $80,000)
Work Schedule
Monday-Friday (40 hours per week, with flexibility)
Job Location
Raleigh, NC
Department
IR-4 Project
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 four analytical laboratories throughout the United States.
Essential Job Duties
Reporting to the National Quality Assurance Unit Manager, the incumbent is a member of the IR-4 Project Quality Assurance Unit and 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). The duties include but are not limited to:
1. 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
- Critically review field data book for accuracy of raw data, a summary of which will be included in reports for compliance with GLP.
- Develop and issue an audit report to Study Director, Testing Facility Management, and 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.
- Analytical Data, Analytical Summary Reports, and Contributing Scientists Reports
- Critically review data and reports from analytical laboratories, seed treatment facilities, and food processing laboratories for compliance with GLP, checking for non-compliance issues.
- Issue an audit report to Study Director, Testing Facility Management, and Laboratory Research Director 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 Analytical Summary or Contributing Science Report.
- In-life Inspections
- Inspect critical phases of field trials and/or associated lab analyses for a study.
- Develop and issue an audit report to Study Director, Testing Facility Management, and Field Research Director/Laboratory Research Director of any non-compliance issues and seek response.
- Review response to audit findings to determine if they were adequately addressed.
- Facility Inspections
- Inspect facilities for compliance to 40 CFR Part 160.
- Develop and issue an audit report to Field Research Director/Laboratory Research Director, Testing Facility Management, and others of any non-compliance issues and seek response.
- Review response from audit findings to determine if they were adequately addressed.
2. 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 teamwork to coordinate any proposed changes or additions to the SOPs with other personnel affected by said changes. Assist with the development of processes and their documentation.
3. 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.
Other Responsibilities
Perform other duties as assigned by the National Quality Assurance Unit Manager. Willing to travel to conduct audits and attend major IR-4 meetings throughout the United States.
Qualifications
Minimum Education and Experience
- Bachelor’s degree in chemistry, plant protection sciences (Entomology, Plant Pathology, Weed Science), horticulture, biochemistry or related field plus at least two years’ experience working in a GxP environment.
- Documented GxP training or similar coursework and 2 years of experience in a GxP regulated environment.
Other Required Qualifications
- Attention to detail.
- Excellent organizational skills; ability to multi-task and coordinate multiple activities in parallel with a sense of urgency.
- Ability to prioritize, plan and schedule.
- Strong oral and written communication skills.
- Investigative decision-making skills.
- Problem identification and resolution skills.
- Critical Thinking.
- Flexibility with supporting scheduled/unscheduled work.
- Excellent interpersonal skills.
- Ability to perform as a contributing and valued member of a team.
Preferred Qualifications
- More than two years working in a US Environmental Protection Agency Good Laboratory Practice regulated environment.
Required License(s) or Certification(s)
- Valid NC driver’s license or the ability to obtain within 60 days of start.
Valid NC Driver's License required
Yes
Commercial Driver's License required
No
Recruitment Dates and Special Instructions
Job Open Date
11/09/2022
Anticipated Close Date
Open until filled.
Special Instructions to Applicants
Please submit a cover letter, CV, and contact information for professional references.
Position Details
Position Number
00109728
Position Type
EHRA Non-Faculty
Full Time Equivalent (FTE) (1.0 = 40 hours/week)
1.00
Appointment
12 Month Recurring
Mandatory Designation - Adverse Weather
Non Mandatory - Adverse Weather
Mandatory Designation - Emergency Events
Non Mandatory - Emergency Event
Is this position partially or fully funded on ARRA stimulus monies?
No
Department ID
110313 - IR-4 Project
AA/EEO
NC State University is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, gender identity, age, sexual orientation, genetic information, status as an individual with a disability, or status as a protected veteran. Individuals with disabilities requiring disability-related accommodations in the application and interview process are welcome to contact 919-515-3148 to speak with a representative at the Office of Institutional Equity and Diversity.
If you have general questions about the application process, you may contact Human Resources at (919) 515-2135 or workatncstate@ncsu.edu.
Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. Degree(s) must be obtained prior to start date in order to meet qualifications and receive credit.
NC State University participates in E-Verify. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States.
If you have general questions about the application process, you may contact Human Resources at (919) 515-2135 or workatncstate@ncsu.edu.
Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. Degree(s) must be obtained prior to start date in order to meet qualifications and receive credit.
NC State University participates in E-Verify. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States.
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