Quality Assurance Auditor

Company: NC State University
Location: Raleigh
Posted on: January 12, 2021

Job Description:

Posting Number: PG190707EP Internal Recruitment : No Working Title: Quality Assurance Auditor Anticipated Hiring Range: Commensurate with Education and Experience ($80,000 - $90,000) Work Schedule: Monday - Friday / 8am - 5pm 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 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 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. 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. Other Responsibilities: Other duties as assigned. Minimum Experience and Education: Require post-baccalaureate credentials or a bachelor---s degree plus alternative or equivalent professional training and experience may be substituted for the advanced degree on an exceptional basis. Other Required Qualifications: Master---s degree in analytical chemistry, the 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. Documented GLP training or similar coursework and 3 years of experience with conducting GLP audits. Must have a comprehensive understanding of US EPA Good Laboratory Practice regulations and current best compliance practices. 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 auditing reports in US EPA GLP regulated environment. Possession of a Registered Quality Assurance Professionals in Good Laboratory Practice (RQAP-GLP) professional credential. 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: 12/07/2020 Anticipated Close Date: Open Until Filled. Special Instructions to Applicants: Applicant required documents: Cover Letter, CV, Contact Information for 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 workatncstatencsu.edu. 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.

Keywords: NC State University, Raleigh , Quality Assurance Auditor, Other , Raleigh, North Carolina