Consultant-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.

We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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!

​Making animals' lives better makes life better- join our team today!

Your role: Quality Assurance

This position is accountable for QC/QA oversight and lifecycle management of assigned contract manufacturing (CM’s) and suppliers ensuring that Elanco products meet all regulatory and internal requirements.

This role will act as QC SME and will actively collaborate with quality, regulatory, technical services, operations, and supply chain counterparts to maintain the routine of quality document reviews/approvals, batch release support and tech agenda as needed.

Including, but not limited to, authoring, reviewing and/or approving method transfer and method validation protocols and reports for the following technologies: parenteral, oral solid dose, non-sterile liquid & Nutritional Health, premix, API, and EPA/parasiticide products.

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Your Responsibilities:


* Assure the robust selection and on-boarding of CMO’s / Suppliers that perform testing for Elanco are in compliance with regulatory cGMP requirements and the Elanco Quality Manual / Directives


* Manage and support the resolution of issues at CMOs/Suppliers, escalate issues appropriately and timely drive corresponding continuous improvement initiatives.


* Support and guide internal functions within Elanco and external partners (e.g.

interpretation of regulations/standards, inspection readiness, etc.)


* Manage contract laboratories that perform testing of commercial products


* Review and approve OOS, OOT Investigations, and deviations related to QC activities and perform assessments and visits of contract manufacturers and laboratories.


* Assist with preparation and review of submission documents


* Provide support for new product launches/acquisitions to ensure compliant systems and procedures are in place to manage new products


* Leverage subject matter expertise in the review and approval of technical documents supporting the validated state of commercial product, including laboratory validation reports, technical documents, and stability reports


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