QAU Specialist

Syngenta; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical/Dental/Vision coverage

401k with company match

Paid time off

Job summary

Syngenta Seeds Field Crops is seeking an entry- to mid-level QAU Specialist to support GLP compliance under EPA FIFRA GLPS. You will monitor studies, audit protocols, and ensure facilities, equipment, and records meet regulatory standards.

You’ll also participate in IT system validations and quality improvement projects within the QA unit. The role requires a scientific degree and GLP experience, with travel to test facilities across the US.

Qualifications

• Bachelor’s or higher in a scientific field with GLP experience.
• Familiarity with EPA FIFRA GLPS and related SOPs.
• Experience auditing protocols, data, and final reports.

Responsibilities

• Audit study protocols, data and final reports to ensure GLPS compliance.
• Travel within the US to inspect test facilities.
• Write and submit audit/inspection reports.
• Maintain communication and relationships with monitored groups.
• Assist in GLP-related IT system validations and quality projects.
• Stay current with regulatory trends and requirements.
• Conduct GLP training for site staff.
• Review SOPs and suggest revisions for compliance.
• Conduct APHIS trials, eco-monitoring, and QM audits as needed.

Skills

GLP standards

Audit & inspection

Communication skills

Team player

Education

College degree in a scientific discipline

Job description

At Syngenta Seeds Field Crops,we'reshaping the future of agriculture and empowering farmers to meet the ever-growing demand for food and fuel.We’rea global Ag Tech powerhouse, headquartered in the United States, with passionate, local experts collaborating with farmers to deliver solutions that create market opportunities.We unite precision breeding, advanced biotechnology trait choice, and digital platforms for unmatched in-field performance.Our seeds help mitigate risks such as disease,insect,weed, and extreme weather pressures, all while promoting sustainable farming practices that protect and enhance our planet. Join our mission of revolutionizing food security and transforming agriculture.

Job Description

Syngenta’s Quality Assurance Unit (QAU) is committed to ensuring compliance with the EPA FIFRA Good Laboratory Practice Standards (GLPS) in 40 CFR Part 160, which is a federal regulatory requirement. We are looking for a QAU specialist to join our Quality Team. This is an entry level to mid-level professional position with extensive career growth opportunities. As a QAU Specialistin the QA Unit, you will primarily be responsible for monitoring studies and facilities to ensure the facilities, equipment, personnel, methods, practices, and records are compliant with federal regulatory requirements as mandated by the EPA. The incumbent will conduct audits and inspections of protocols, audit/inspect study activities, data, and final reports. Additionally, the incumbent will evaluate compliance as a supporting member of teams focused on computer systems validations, process improvement, and other quality management systems within the Syngenta Seeds organization.

Accountabilities:

• Audit study protocols, data and final reports to ensure compliance with EPA FIFRA GLPS regulations and Syngenta Standard Operating Procedures (SOPs)
• Travel within the US to inspect test facilities
• Write and submit audit/inspection reports
• Maintain communication and develop sound relationships with monitored groups
• Work on and assist various projects (e.g., computerized and IT system validations, industry-led groups, etc.) within the test facility and site to ensure compliance with GLPS and internal procedures/policies
• Stay current with trends and regulatory requirements
• Conduct training for Good Laboratory Practices Standards (GLPS) and quality assurance for applicable site staff.
• Review of QAU and laboratory SOPs and suggest revisions where appliable for improved compliance outcomes
• Conduct APHIS trial assessments, eco-monitoring audits, and QM Stewardship audits as necessary

Qualifications

• College degree in a scientific discipline with 3 to 5 years relevant experience with GLPs
• Multi-disciplinary studies, GLP Standards, GLP Advisories, QAU and Departmental SOPs, internal QAU memoranda, master schedule system, familiarity with equipment and methods, study protocols and EPA submittal guidelines
• Previous employment in a scientific position in the areas of field biology, biotechnology, chemistry, analytical laboratory or QA auditor for a regulated industry. Experience and knowledge of the EPA FIFRA GLPS would be a definite plus
• Experience with computerized systems validations, IT systems and networks, as related to GLP compliance
• Acquire training in all aspects of QAU monitoring for Syngenta Seeds
• Assist in designing and delivering GLP training to customers and stakeholders
• Provide ongoing monitoring of studies/ facilities at Syngenta and contract research organizations (CROs)
• Work as a team player within the QAU to be flexible and assist with all assignments

Desired Qualifications:

• Candidate should have strong skills in communication, interpersonal relationships, organizational knowledge, planning and organization, standard office software and problem solving.
• Expectations of the role are to advise and resolve GLP issues, conduct study and facility audits and inspections, issue audit and inspection reports, communicate well verbally and in writing, handle multiple tasks through prioritization, give/receive feedback openly and effectively and be a team player
• Critical Attributes: Concern for standards, attention to detail and thoroughness
• Demonstrate leadership by example
• Flexibility to ensure EPA submission deadlines are met
• Takes responsibility and initiative to make things happen

Additional Information

What We Offer:

• A culture that celebrates belonging and collaboration, promotes professional development and strives for a work-life balance that supports the team members. Offers flexible work options to support your work and personal needs.
• Full Benefit Package (Medical,Dental& Vision) that starts your first day.
• 401k plan with company match, Profit Sharing & Retirement Savings Contribution.
• Paid Vacation, Paid Holidays, Maternity and Paternity Leave, Education Assistance, Wellness Programs, Corporate Discounts, among other benefits.

Syngenta is an Equal Opportunity Employer and does not discriminate in recruitment, hiring, training,promotionor any other employment practices for reasons ofrace, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

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