Associate-Quality Assurance-1

ElancoWinslow, ME
1d

About The Position

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today! Your Role: Quality Assurance Associate As a Quality Assurance Associate , you will be part of the Quality team to support cGMP operations and ensure compliance across manufacturing processes. In this role, you will be responsible for maintaining quality systems, supporting batch disposition, and partnering cross-functionally to drive compliance, investigations, and continuous improvement.

Requirements

  • Education: Bachelor’s Degree in a Science or Engineering field (or equivalent experience)
  • Experience: Experience in quality systems, manufacturing, or regulated environments
  • Top 2 skills: Strong problem-solving/root cause analysis + effective communication and collaboration

Nice To Haves

  • Experience in pharmaceutical, biotech, or regulated (FDA/USDA) environments
  • Knowledge of Lean, Six Sigma, or Operational Excellence methodologies
  • Experience with deviations, CAPAs, and quality investigations
  • Strong technical writing and documentation review skills
  • Ability to lead and influence in a cross-functional team environment

Responsibilities

  • Support batch disposition for incoming, in-process, and finished materials
  • Review and approve quality documents including deviations, change controls, and validation protocols
  • Partner cross-functionally to investigate non-conformances and drive CAPAs
  • Provide guidance to operations teams to ensure compliance with quality systems and regulatory standards
  • Support internal and external audits and contribute to continuous improvement initiatives
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