Quality Assurance Unit Specialist
Quality Assurance Unit Specialist
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Job Description
Through leading innovations we help farmers around the world meet the challenge of feeding a growing population and taking care of our planet. To support this challenge Syngenta is currently seeking a Quality Assurance Unit Specialist in Durham NC.
The Quality Assurance Unit (QAU) will ensure compliance with the EPA FIFRA and Good Laboratory Practice Standards (GLPS). The role 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 and 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.
- Assist with computerized and IT system validations and provide guidance to meet compliance requirements.
- Stay current with trends and regulatory requirements.
- Conduct training for Good Laboratory Practices Standards (GLPS) and quality assurance to applicable site staff.
- Review 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 :
Required:
- A minimum of a 4-year degree.
- A minimum of 3 years of relevant experience with GLPs.
- Must be eligible to work in the United States without sponsorship support from Syngenta.
- Up to 20% travel is required for this role.
Preferred:
- Experience in the biology biotechnology chemistry analytical laboratory and/or QA auditor for a regulated industry.
- Experience and knowledge of the EPA FIFRA and GLPS.
- Experience with computerized systems validations IT systems and networks as related to GLP compliance.
- Knowledge of GLP Trials GLP Standards GLP Advisories QAU and Departmental SOPs internal QAU memoranda and master schedule system.
- Familiarity with lab equipment and methods study protocols and EPA submittal guidelines.
Additional Information :
What We Offer:
- A culture that celebrates diversity & inclusion 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 has been ranked as atop employerby Science Journal.
Learn more about ourteamand ourmission here: is an Equal Opportunity Employer and does not discriminate in recruitment hiring training promotion or any other employment practices for reasons of race color religion gender national origin age sexual orientation marital or veteran status disability or any other legally protected status.
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Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
