Quality Control Coordinator

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!

Your Role: Quality Control Coordinator

The QC Senior Associate, reporting to the Quality Control Manager, oversees sample coordination for raw materials, bulk product, final product, and experimental samples submitted to Quality Control.

This role requires collaboration with other departments to ensure accurate labeling, storage, and testing, along with organizing controlled documentation and distributing it to laboratories and regulatory agencies.

Additionally, the Senior Associate reviews and corrects primary testing documentation and participates in audits and inspections.

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Your Responsibilities:


* Manages the distribution of controlled documents and ensures proper handling of production samples, including chain of custody maintenance and storage.


* Oversees the submission and shipping of samples, including USDA submissions, following regulatory guidelines.


* Assembles testing documentation packets and summary reports for QA release submissions and distributes non-release testing data reports.


* Manages QC material ordering, supply room organization, and document filing.


* Develops, reviews, and implements SOPs, oversees electronic systems (e.g., LIMS, SAP), and participates in audits and inspections.

What You Need to Succeed (minimum qualifications):


* HS diploma or GED and at least 5 years of experience, or BA or BS degree in a scientific discipline preferred with at least 3 years of experience, in cGMP or cGXP at an operational level supporting manufacturing in a pharmaceutical or biotech environment.


* Prior experience related to quality control testing or systems in a pharmaceutical environment.


* Analytical Skills: Highly analytical and strong advocate for process improvement.

What will give you a competitive edge (preferred qualifications):


* Experience in Materials Management for USDA or FDA regulated industries.


* Experience with LIMS, SAP, JMP, Veeva Vault.


* Excellent technical writing skills.


* Working knowledge of VICH, USDA and/or EU GMP regulations for veterinary biolog...