Senior Associate - Quality Assurance

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:

As a Quality Assurance Representative, you will serve as a primary guardian of product quality and regulatory compliance at the Speke site. This role is responsible for the final disposition of materials and products, ensuring every batch meets the required cGMP standards.

A key member of the cross functional Process Team you will provide advice and support on all manufacturing issues, including deviations and change control. You will drive continuous improvement through regular on-plant GEMBA walks and by monitoring trends in Quality data. This position ensures the integrity of manufacturing processes and the safety of Elanco’s animal health products.
 

Your Responsibilities:

• Review and release raw materials, intermediates, and finished products
• Assess batch records, deviations, and ensure compliance with cGMP standards
• Provide quality guidance on manufacturing issues, change control, and deviations
• Support operations through on-plant presence and regular Gemba walks
• Lead investigations, support audits, and drive effective CAPAs
• Monitor quality trends and contribute to continuous improvement initiatives
• Maintain and approve key quality documentation (e.g. SOPs, protocols, agreements)

What You Need to Succeed (minimum qualifications):

• Degree level (or equivalent) with relevant experience (5 years +) working in a pharmaceutical company in a quality related function.

What will give you a competitive edge (preferred qualifications):

• Experience in Pharmaceutical or other regulated industry (i.e. food, healthcare)
• Able to demonstrate strong written and oral communication skills
• Able to demonstrate strong root cause analysis skills
• Experience in using Electronic Quality Management System software and SAP

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 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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.