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Quality Assurance Auditor

Employer
NC State University
Location
Raleigh, NC
Closing date
Jun 24, 2021
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Job Details

Posting Number:

PG190917EP

Internal Recruitment :

No

Working Title:

Quality Assurance Auditor

Anticipated Hiring Range:

Commensurate with Experience ($80,000 - $90,000)

Work Schedule:

40 hours/week

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 five 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).

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:
    • Critically review field data 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:
    • Critically review Contributing Science Report 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 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 GLP requirements 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.

Other Responsibilities:

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.

Minimum Education and Experience:

  • Master’s degree in analytical chemistry, plant protection sciences (Entomology, Plant Pathology, Weed Science), horticulture, or related field, with 3 years of relevant experience, or Bachelor’s degree in analytical chemistry, the plant protection sciences (Entomology, Plant Pathology, Weed Science), horticulture, or related field, with 6 years’ of alternative or equivalent professional training and/or experience.

Other Required Qualifications:

  • Documented GxP training or similar coursework and 3 years of experience in a GxP environment.
  • Excellent interpersonal skills and the ability to perform as a contributing and valued member of a team.
  • Attention to detail, with the ability to prioritize, plan and schedule. Flexibility with supporting scheduled/unscheduled work.
  • Excellent organizational skills; ability to multi-task and coordinate multiple activities in parallel with a sense of urgency.
  • Strong oral and written communication skills.
  • Investigative decision-making skills, problem identification and resolution skills.

Preferred Qualifications:

  • 5 years as QA in a US EPA Good Laboratory Practice environment with a comprehensive understanding of GLP regulations and current best compliance practices.

Required License(s) or Certification(s):

  • Valid NC driver’s license or the ability to obtain with 60 days of start.

Valid NC Driver's License required:

Yes

Commercial Driver's License required:

No

Job Open Date:

04/23/2021

Anticipated Close Date:

Open Until Filled

Special Instructions to Applicants:

In addition to your application please submit a cover letter, CV, and the contact information for at least three (3) professional references.

Position Number:

00108268

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/EOE:

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.

If you have general questions about the application process, you may contact Human Resources at (919) 515-2135 or [email protected] Individuals with disabilities requiring disability-related accommodations in the application and interview process, please call 919-515-3148.

Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. If highest degree is from an institution outside of the U.S., final candidates are required to have their degree equivalency verified at www.wes.org or equivalent service. 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.

Organization

NC State: Think and Do

NC State was founded with a purpose: to create economic, societal and intellectual prosperity for the people of North Carolina and the country. We began as a land-grant institution teaching the agricultural and mechanical arts. Today, we're a pre-eminent research enterprise with 12 colleges excelling in all major academic fields.

NC State studentsOur 34,000 high-performing students take what they learn in the classroom and apply it in the real world by conducting research, working in internships and co-ops, and performing acts of world-changing service. That experiential education ensures that they leave here ready to lead the workforce. NC State's 13:1 student-faculty ratio is one of the reasons why we're the best college for your money in North Carolina (Money) and the No. 5 best value among public universities nationally (U.S. News & World Report).

Overcoming Challenges, Improving Lives

NC State is one of only two universities in the nation leading two National Science Foundation Engineering Research Centers — one developing wearable, self-powered health monitors, and the other researching smart-grid technology. We’re also leading interdisciplinary efforts to curb nuclear proliferation, help farmers confront climate change and build a new American manufacturing sector.

Our research doesn't just get published in a journal or sit on a shelf; it makes an impact. NC State is No. 6 nationwide in commercialization agreements based on university research, and we're No. 2 among universities without a medical school. Our Cooperative Extension Service provides research-based information to citizens in all 100 North Carolina counties. In addition, our industrial extension unit — Industry Expansion Solutions — has created an economic benefit for the state's manufacturers averaging $149 million per year since 2005.

Bright Minds Creating a Bold Future

NC State’s 9,000 faculty and staff are world leaders in their fields, bridging the divides between academic disciplines and training high-caliber students to meet tomorrow’s challenges. NC State students won two Goldwater scholarships, five Fulbright scholarships, one Churchill scholarship and a record-breaking 25 National Science Foundation graduate research fellowships in the 2016-2017 academic year. In addition, 25 faculty are members of the National Academies.

NC State bldg in darkOur Centennial Campus, an award-winning public-private research campus, is home to more than 70 partner organizations working alongside more than 70 NC State research and academic units. Centennial is also the location of the innovative Hunt Library, which Time magazine has dubbed “the library of the future.”

In Raleigh and Around the World

It all happens in one of the best cities in America. A top spot for job-seekers and tech professionals, Raleigh is nationally recognized as a leading urban center:

NC State building oldWith Durham and Chapel Hill, Raleigh anchors the Research Triangle, a national hotspot for high-tech enterprise. The top companies in the region — including IBM, Cisco Systems, SAS Institute, Biogen Idec and GlaxoSmithKline — are among the country’s best employers. They also lead the way in hiring new NC State graduates.

More than 130 years after its creation, NC State continues to make its founding purpose a reality. Every day, our career-ready graduates and world-leading faculty make the fruits of learning and discovery available to people across the state, throughout the nation and around the world.

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