Senior Associate - Quality Assurance

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.

As 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.

• 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).

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

• 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.

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.