Overview

Do you have experience auditing against EPA’s GLP regulations to meet TSCA and FIFRA requirements? Are you an experienced GLP QA auditor? If so, we want you to join our Global QA team as a QA Auditor, Crop Protection and Chemical EPA in Greenfield, IN.

Covance by LabCorp plays an important role in maintaining good plant health and increasing global crop yields to feed an ever growing global population. From physicochemical testing to complex safety assessment and through to submission and approval, our team helps to navigate many data requirements and different national and regional regulations. Be a part of this research and development team and make an impact in environmental and global population while growing your career.

Position Overview

  • Leveraging your education in a related scientific discipline and your experience in the Agricultural and/or Non-crop Chemical Industry, you will develop and implement strategies to assure U.S. and global GLP compliance of crop protection registration studies and both internal and external facilities, ensure regulatory success and take complete accountability for the projects residing within the team.
  • Relying on your proven experience in GLP Quality Assurance Auditing, you will establish clear expectations for high performing GLP auditors regarding customer relationships (internal business units and regulatory authorities).
  • Successfully engaging outside the organization, you will take a leadership role in monitoring EPA regulatory activities through interactions in industry associations and regulatory and scientific associations, leading committees and working groups.
  • Applying your strong comprehensive knowledge of FIFRA and OECD Good Laboratory Practice Regulations, you will train and mentor new employees in EPA FIFRA Good Laboratory Practice requirements and internal company processes.
  • Your effective written and verbal communication skills will serve you well as you communicate and coordinate efforts with global members to assure GLP issues are resolved in a way that will satisfy US EPA GLP regulatory requirements.
  • Contribute to local Quality initiatives aimed at improving compliance and/or efficiency of the local QA organization
  • Author QA SOP
  • Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
  • Report on relevant quality metrics (for multiple topics/departments) and highlight trends
  • Provide consultation to the operational team (e.g. as they revise/write controlled documents)
  • Delivery of training in performance of audits (basic, intermediate audit activities)

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Education/Qualifications:

  • A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
  • Experience may be substituted for education.

Experience:

  • 3 years’ in regulatory environment (experience in GLP role)
  • Working knowledge of EPA Toxic Substances Control Act (TSCA), preferred
  • Working knowledge of Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), preferred
  • Knowledge of industry quality systems/standards and able to apply (applicable) regulations in order to monitor compliance
  • Experienced GLP auditor
  • Experienced in process improvement
  • Clear communication skills, including ability to provide clear feedback
  • Able to clearly articulate processes in order to provide training
  • Able to influence process improvement initiatives / offer solutions

Tagged as: EARLY CAREER, MID TO SENIOR LEVEL

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