QAU Specialist

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 Specialist in 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