At Neogen Corporation, we believe in fostering a culture of innovation, collaboration, and continuous improvement. As a Quality Specialist III, you will have the opportunity to work alongside talented professionals who are passionate about making a difference in the world. We offer competitive compensation and benefits packages, as well as opportunities for professional growth and development. Join us in our mission to protect and enhance global food and animal safety!
This role follows an onsite model to accommodate business needs while maintaining team collaboration.
Summary: Manages, coordinates and actively participates in activities related to all Quality System functions such as audits, corrective actions, process and equipment validations, supplier quality and general documentation management to ensure effective, efficient compliance with ISO/FDA quality management system principles and customer expectations specific to Neogen’s Food Safety Division.
Essential Duties and Responsibilities:
Ability to define and understand quality terms, definitions, concepts and processes. Must be able to apply quality tools, including continuous improvement techniques, problem solving and lean concepts.
Must be able to interpret information and data. Familiar with statistical terminology and techniques. Must be able to collect data for specific techniques. Must be able to interpret control chart results, process capability and specification limits. Ability to use data to report leading indicators.
Must have calibration/qualification knowledge, understand measurement and test equipment tools for various applications and how to assess tool accuracy and precision. Must understand the concept of calibration standards and traceability.
Must understand and apply inspection concepts, techniques and processes. Able to understand sample characteristics, types, and selecting samples from lots. Able to identify and segregate non-conforming material and be familiar with material review process.
Able to understand, apply and communicate various quality audit types and their components, tools and techniques. Able to apply quality tools and process improvement techniques while performing internal and external audits. Appraise process during audits using process performance indicators.
Understand risk assessment and mitigation. Must be able to apply the elements of corrective actions, such a prevention, root cause analysis, failure mode and effects analysis (FMEA), and the control of non-conforming products.
Review and approve root cause and actions planned and perform effectiveness checks for corrective actions.
Know the Plan-Do-Check-Act (PDCA) cycle and understand process concept.
Identify continual improvement actions, plan assessments, collect audit evidence and explain continual improvement to others. Help develop measurement systems to determine organizational improvement.
Must be able to identify and execute various process, equipment and cleaning validation and qualification methods. Development of validation protocols associated with equipment installation and new processes.
Other duties as may be assigned by management
Qualifications and Experience:
Minimum BS degree in Quality Management, Engineering, Biochemistry, Chemistry, Microbiology, Food Science or other applicable degree.
5+ years' experience in higher level functions supporting a Quality System in an ISO/FDA regulated environment.
Experience ensuring medical device compliance to 21CFR820
Solid understanding of interaction between compliance and business needs/functions required.
ASQ certification considered a plus.
Please press Apply to submit your application.
WHO IS NEOGEN:
From farm to fork, we offer solutions to enhance the quality, quantity and safety of the global food supply. Our food safety diagnostics are used within farming operations to the production facilities of most of the world’s best-known food companies. Neogen’s solutions are critical to the health and well-being of our customers’ operations – and in turn their consumers. What we do matters!
Neogen’s culture combines stability with a deep believe in providing professional and personal growth. Our Pillars of Trust – the principles which guide our everyday decision—making, include Openness, Honesty, Credibility, Respect, and Service. It’s the belief in these characteristics that provide a consistent, happy and healthy work environment for our employees.