Quality Assurance Auditor (Field Based)

ERM Raleigh , NC 27611

Posted 3 weeks ago

ERM is hiring a Quality Assurance Auditor with a strong background in agriculture and biology to support our client in Research Triangle Park, NC. The Quality Assurance Auditor will manage and maintain relevant Standard Operating Procedures, perform facility and critical phase audits, perform data and report reviews, and provide GLP training to staff. This is a limited-term consulting position for a duration of up to 1 year and the possibility of renewal.

RESPONSIBILITES:

  • Working in a GLP environment

  • Responsible for audits of scientific reports in compliance with registration requirements of agrochemicals

  • Conduct protocol in-phase, data and report audits of laboratory and field studies including product chemistry, analytical method validation, environmental fate studies, residue and efficacy studies

  • Conduct regulatory inspections according to 40 CFR Part 160

  • Review study reports, notebooks and data tables for compliance with Good Laboratory Practices

  • Report findings from audits and inspections to the study director and management personnel

  • Prepare periodic reports to study directors and management personnel

  • Sign the quality assurance (QA) statement in the final report

  • Work with other Quality Assurance staff to maintain Standard Operating Procedures (SOP)

  • Maintain a copy of the master schedule, study protocols and QAU file for GLP studies

  • Develop and maintain strong communication and working relationships with internal and external teams

  • Communicate and closely co-operate with our clients, on-site at client locations

  • Other related work as requested

REQUIREMENTS:

  • Undergraduate degree in biology, chemistry or related discipline strongly preferred

  • Experience auditing reports under 40 CFR 160

  • Knowledge of Good Laboratory Practices and some years of professional experience

  • Knowledge of plant protection product data development and analytics

  • Previous experience as a Quality Assurance Auditor or equivalent strongly preferred

  • Experience in agriculture or regulatory science strongly preferred

  • Experience in Good Laboratory Practices and/or a regulated industry preferred

  • Experience in an agriculture biology laboratory including pesticides and/or seeds and traits, and/or crop products

  • Experience with bio analytical instruments and data

  • Demonstrated excellent attention to detail, organizational skills, and ability to prioritize work

  • Strong communication skills, both verbal and written

  • Good interpersonal skills

  • Ability to work independently and to succeed in a fast-paced environment

  • RQAP Certified highly desired

  • Self-motivated with the ability to work in a team

  • Valid driver's license

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Quality Assurance Auditor (Field Based)

ERM