Associate-Quality Assurance-1

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:  Associate, QA

Responsible for supporting the site core quality systems to ensure the quality and compliance of veterinary biologics is compliant with GMP standards and guidelines set forth by regulatory agencies.

Specific focus is on the issuance and control of GMP documents and the review of completed records.

Your Responsibilities:


* Review, issuance and reconciliation of controlled records authorized departments in accordance with local and global procedures and in accordance with GMP as such times as is needed to support critical Manufacturing activities.


* Final Product Batch Release:
+ Review of critical process parameters.
+ Ensure all production conditions have been met as per registered documents.
+ Ensure all final product testing specifications have been met as per registered documents.
+ Preparation of release documentation for submission to regulatory authorities or Qualified Person (e.g., Declaration of Compliance, Application for Serial Release, etc.).
+ Inventory control movements in SAP.


* Responsible to work within and enforce the established quality systems based on the Elanco Global Quality Standards and GMP guidelines such as change control, deviation, root cause investigation and CAPAs, etc.


* Management (tracking and trending) of systems to ensure timely closure and follow up where actions are required and prepare the required information to support the Quality Leadership Team meetings.


* Quality Department Support:
+ Providing guidance and working closely with manufacturing personnel.
+ Review and approval of quality documents such as SOPs, forms, protocols, etc.
+ Writing/revision of standard operating procedures and forms when applicable.

What You Need to Succeed (Minimum Qualifications):


* Minimum BSc or equivalent combination of education and experience.


* Required Experience: Training in QA, cGMP, or an equivalent quality s...