Quality Assurance Associate

Location: Winslow, ME

Time Type: Full time

Job Description

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. 

Your 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.

What You Need to Succeed (minimum qualifications):

• B.S. Degree or equivalent (Science or Engineering related degree preferred) with 3+ years of relevant experience.

• Familiarity with applicable Global Regulatory, Quality and ISO standards such as FDA (Food and Drug Administration), EU (European Union) GMP, USDA (United States Department of Agriculture), and CFIA (Canadian Food Inspection Agency).

• Proven quality assurance experience in a regulated environment.

What Will Give You the Competitive Edge (preferred qualifications):

• 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.

Additional Information:

• Location: Winslow, Maine

• Must not have contact with avian species (birds) at home due to the nature of the manufacturing.

Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco, we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! 

Elanco Benefits and Perks: 

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: 

• 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 

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status