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
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
Benefits
Health insuranceVision insurance
Additional Information
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.
Elanco · United Kingdom