Quality Assurance Associate

Elanco • Winslow, ME

93d

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 The Quality Assurance Associate provides daily assistance and guidance to issues such as non-conformance investigations, change controls, procedure/manufacturing batch record changes, validations, batch disposition, and qualification activities. The QA Associate works as a team member within the operations teams to achieve site goals while maintaining a strong quality mindset.

Requirements

• B.S. Degree or equivalent in Microbiology/Biology/Chemistry/Engineering (Science or Engineering related degree preferred).
• Familiarity with applicable Global Regulatory, Quality and ISO standards such as FDA, EU GMP, USDA, and CFIA.
• Proven quality assurance experience in a regulated environment.

Nice To Haves

• M.S degree is highly preferred.
• Root cause analysis and troubleshooting skills.
• Demonstrate strong oral, written, and interpersonal skills.
• Strong ability to work on a team and lead without authority.
• Technical writing skills.

Responsibilities

• Ensure robust quality and compliance: Oversee and monitor quality systems, conduct thorough document reviews, and support regulatory inspections to maintain high standards.
• Facilitate batch disposition: Assist with the timely disposition of incoming, semi-finished, and finished materials, ensuring adherence to quality protocols.
• Lead and mentor on quality matters: Coach and guide operations and support personnel, fostering a strong understanding and application of quality principles.
• Drive deviation management and continuous improvement: Collaborate cross-functionally to investigate non-conformances, deviations, and CAPAs, leveraging Six Sigma tools and supporting Lean initiatives.
• Provide quality guidance for projects: Serve on project teams, offering expert input to ensure compliance and quality attributes are met throughout project lifecycles.

Benefits

• Multiple relocation packages for eligible roles
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Up to 6% 401K matching

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees