Quality Assurance Associate

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!

Position Role:

The QA Associate, Product Release reports directly to the QA Manager.

This individual will be responsible for auditing products for final disposition for the Elanco Elwood, KS site.  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 and serves as a QA representative and SME on assigned internal and external project/process flow teams to solve quality related issues.

Your Responsibilities:


* Responsible for control of official batch related records into and out of QA Department including: Performing batch record review, status notifications, assignment of stickering, and serial file reviews for in-process or product release, and batch audits and final disposition for manufactured products for compliance to GMP/Outline.


* Perform review and approval of executed records (Batch Records, Manufacturing Directions, Solution Records, Autoclave Records, Logbooks, QC Testing) and Certificates of Analysis and Certificates of Compliance for batch release.


* Perform Impact assessments on products to comply with USDA or other GMP regulatory requirements.


* Review and/or approve local SOPs, Test Specifications, Master Production Record Review, Special Outlines and Outlines of Production.


* Prepare, Review and/or Submit APHIS Form 2008’s against applicable Outlines of Production for USDA release.


* Ensure product documentation is complete and compliant with specifications, SOPs, and regulations.


* Submits product release data for monthly KPI and Metric reports.


* Assist with internal, regulatory, and corporate audits to ensure compliance with regulations, quality standards and guidance documents and follow up on audit responses and completion of assigned CAPAs by target due dates.


* Lead, mentor, and coach operations and support personnel on quality and good documentation matters.

What You Need to Succeed (Minimum Qualification):


* Bachelorâ...