Quality Assurance Associate, On the Floor (Off Shift)

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: Quality Assurance Associate, On the Floor (OTF)

 

Shift: Flexible based on availability, but will cover some 2nd and 3rd shift hours Monday-Friday.

 

This position supports the Process Teams by tracking/reporting/and defining continuous improvement goals, on-the-floor batch record review/determining root cause for deviations/investigation report writing, coaching/training personnel on GMP/GDP, auditing production processes for compliance to global and local procedures, and closely working with and reporting to the Process Team Lead and Quality Lead.

 

Your Responsibilities:


* Review and approve product batch records and technical documentation associated with validation, deviations or change control activities (media fills, etc.).


* Track/report/and define continuous improvement goals, determine root cause for deviation/CAPA reports, and subsequent communication back to the Process Team.


* Audit production processes for compliance with global and local procedures and either create new or revise existing procedures as changes occur.


* Develops training plans and trains/qualifies others, including training outside of area of responsibility.


* Demonstrates understanding of regulations for various countries and provides input or approval accordingly.

 

What You Need to Succeed (Minimum Requirements):


* BS degree in relevant scientific discipline and a minimum 2 years of relevant experience in quality assurance or biological production OR High School Diploma/GED with a minimum 5 years of relevant experience in quality assurance or biological production.


* Previous experience with USDA/FDA regulatory requirements in a biological production environment. 


* Previous experience utilizing computer programs such as Microsoft suite, SAP, Veeva, Learning One Source and other relevant electronic applications.

 

What Will Give You a Competitive Edge (Preferences):


* Ability to make decisions with minimal supervision regarding the acceptability of product based on documentation provided.


* Excellent attention to detail.


* Continuously demonstrat...