Analista Sênior Garantia da Qualidade

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: e

As a Senior Associate - Quality Assurance, you will be part of the Elanco External Manufacturing (EEM) Americas Hub team to deliver quality oversight for products manufactured by Contract Manufacturing Organizations (CMOs).

In this role, you’ll be responsible for advancing Good Manufacturing Practices (GMP) compliance, product release, and quality event management to ensure products meet global standards and local legislation.

Your Responsibilities:


* Monitor third-party operations through site visits, maintain Quality Technical Agreements (QTAs), and ensure compliance via risk assessments and supplier qualifications.


* Review and evaluate complex documentation, including manufacturing instructions and Certificates of Analysis (COA), to perform product release activities.


* Manage the administrative flow of quality documents within Veeva, including Master Batch Records (MBR) and specifications, ensuring alignment with GMP standards.


* Initiate and manage the administrative flow of internal and external deviations, change controls, CAPAs, and support complaint investigations.


* Record monthly quality metrics, compile data for performance reviews, and support continuous improvement initiatives, product launches, and regulatory audits.

What You Need to Succeed (minimum qualifications):


* Bachelor’s Degree in Pharmacy, Biochemistry, or a related technical discipline.


* A minimum of 4 years of experience in pharmaceutical quality assurance or quality control.


* Strong knowledge of Good Manufacturing Practices (GMP) and Quality Systems (Veeva, SAP).


* Advanced English proficiency.

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


* Proficiency in Spanish.


* Experience with technology transfers, validations, and stability studies.


* Strong attention to detail to ensure high quality and accuracy in batch release and documentation management.


* Action-oriented mindset with the ability to take on new challenges with a sense of urgency.


* Proven ability to build strong relationships and deliver customer-centric sol...