Quality Assurance Associate - Process Team (Project Management)

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 Assurance Associate - Process Team

The Quality Assurance Associate is responsible to oversee the Quality Assurance responsibilities for the associated process team and quality operations process, to provide daily assistance and guidance to issues such as non-conformance investigations, change controls, quality training, review and approval of documents and to ensure the adherence to Elanco Quality standards and Regulatory agencies.   The QA Associate works as a team member within the operations teams to achieve site goals while maintaining a strong quality mindset. 

Your Responsibilities:

• Quality Guidance and Oversight: Provides routine and non-routine quality guidance, training, and batch record review within the manufacturing environment. This includes a daily presence on the production floor and assisting with batch disposition for incoming, semi-finished, and finished materials.

• Document Review and Approval: Reviews and approves a variety of process team quality documents, such as SOPs, forms, protocols, MPRs, and OJTs to ensure documentation accuracy and adherence to quality standards.

• Distribution and Product Release Support: Oversees distribution area quality, including label approvals, issuing Certificates of Analysis (CoAs), managing retain samples, and coordinating SAP quality movements.

• Deviation and CAPA Management: Manages deviations and corrective/preventative actions (CAPAs), including preparation, review, approval, and effectiveness verification. This addresses non-conformances and drives continuous improvement.

• Quality System Support and Representation: Supports the quality system through SAP expertise, training, participation in meetings and projects, and mentoring site personnel on quality matters to ensure quality system effectiveness and promote a quality-conscious culture.

What You Need to Succeed (minimum qualifications):

• B.S. Degree (Microbiology/Biology/Chemistry/Engineering degree preferred)

• Root cause analysis and troubleshooting skills

• Technical writing skills

What Will Give You the Competitive Edge (preferred qualifications):

• M.S highly desirable.

• Proficiency with applicable computer systems, such as SAP, Veeva and Microsoft Office

• Knowledge of or experience in Lean, Six-Sigma or Operational Excellence

• ASQ certification a plus.

• Experience working in an FDA or USDA regulated industry

Additional Information:

• Must not have contact with avian species (birds) at home due to the nature of the manufacturing.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status