QA Consultant/Sr. Associate, Product Release & Responsible Person Delegate

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: QA Consultant/Sr.

Associate, Product Release & Responsible Person Delegate

 

This role for reports directly to the Director of QA.

This individual will be responsible for auditing products for final disposition, and for ensuring all manufacturing, sampling, and testing activities comply with regulatory authority regulations/associated outlines of product/Elanco standards for the Elanco Elwood, KS site.

From a product release function, this position assures that all specifications and Outline of Production requirements are met prior to each stage of release leading up to Form 2008 submissions to comply with USDA and GMP regulatory requirements.

As a Responsible Person delegate, this position will ensure accuracy/completeness of submissions to Health Authorities, and ensure product quality and compliance with regulatory requirements for released batches.

 

Your Responsibilities:


* Work with the Quality Organization and other functions to ensure all manufacturing, sampling, and testing activities comply with regulatory authority regulations, associated outlines of production, and Elanco standards.


* Perform batch record review, status notifications, assignment of stickering, and serial file reviews for in-process or product release.


* Perform batch audits and final disposition for manufactured products for compliance to GMP/Outline to ensure products released comply with all requirements of relevant regulatory authorities, outlines of production, and elanco procedures.


* Execute second person verifications (2PV) for documents and more generally submissions to Health Authorities


* Serve as a QA representative and SME, and as a delegate for the site Responsible Person on assigned internal and external project/process flow teams to solve quality related issues

 

What You Need to Succeed (minimum qualifications):


* Education: Bachelor’s degree, preferably in a scientific discipline.


* Experience: 5+ years of manufacturing and quality experience, preferably in a quality function.


* Top 2 skills:  Must be able to utilize all elements of the quality system t...