Senior Associate – Quality Assurance

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: Senior Associate – Quality Assurance

As a Senior Associate – Quality Assurance, you will play a crucial role in supporting Clinton Manufacturing Operations and ensuring that quality systems adhere to Good Manufacturing Practices (GMP).

In this position, you'll be responsible for facilitating compliance, supporting continuous improvement initiatives, and providing guidance to operational staff.

Your Responsibilities:


* Provide production floor support, including assistance with procedures, master batch records, and quality system monitoring, while maintaining GMP compliance and preparing for regulatory inspections.


* Execute batch record review and support batch release processes in accordance with internal procedures and regulatory requirements, utilizing SAP for documentation, materials management, and quality-related transactions.


* Facilitate continuous improvement initiatives by coaching and supporting deviation investigations, change control proposals, and quality system enhancements.


* Collaborate with the area director and cross-functional teams to identify and implement improvements through self-inspections and internal audits.


* Offer guidance and feedback to operational staff, applying principles consistent with CSQA standards to ensure data integrity and support computer system validation.

What You Need to Succeed (minimum qualifications):


* Education: Bachelor’s Degree or equivalent experience in a science-related field preferred.


* Required Experience: A minimum of 3 years of experience in cGMP within pharmaceutical manufacturing.


* Top Skills: Strong proficiency in computer systems (Microsoft Office, SAP, Document Management, Maintenance Management, Inventory, Quality Systems) and excellent communication skills.

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


* Experience in Quality Assurance, Quality Control, or Manufacturing in a regulated environment.


* Proven ability to prioritize and manage multiple tasks effectively.


* Strong problem-solving ...