Associate-Quality Assurance-1

As a Quality Associate, you will provide critical production support to the QA Release Group and Process Team. Your primary purpose is the review and approval of developmental, new, and revised product batch records and technical documentation (e.g., for validation, deviations, change control) to ensure compliance with all regulatory requirements (USDA, FDA, EU, etc.). You will serve as a key resource for projects, assist with audits, and support continuous improvement goals, playing a vital part in the release of products that advance animal health., * Perform detailed review and approval of batch records and associated technical documentation for routine production, validation, and change control activities to ensure compliance with USDA, FDA, and EU regulations.

• Perform detailed review and approval of batch records and associated technical documentation for routine production, validation, and change control activities to ensure compliance with USDA, FDA, and EU regulations.;margin-top:5.0pt;”>Perform detailed review and approval of batch records and associated technical documentation for routine production, validation, and change control activities to ensure compliance with USDA, FDA, and EU regulations.

• Provide real-time, on-the-floor quality support for batch reviews, process auditing, and quality guidance to production personnel and the Process Team.
• Support the deviation management process by identifying non-conformances, determining root cause, and participating in investigation report writing.
• Assist with internal and external inspection audits by helping with preparation and response, and support the Process Team by tracking and reporting on continuous improvement goals.
• Execute usage decisions and release transactions in SAP to manage product movement and final disposition for product release.

The Associate-QA Release ensures the compliance of biological products through the review and approval of batch records and technical documentation. * P1 (Quality Associate): Entry-level quality production support focused on routine batch review and maintaining basic regulatory compliance. * P2 (Sr. Quality Associate): Quality Subject Matter Expert (SME) for all production process flows with responsibility for the site’s more complex Process Team(s).

• Education:Education:Education: Bachelor’s Degree in a scientific discipline; or a High School Diploma / GED with equivalent relevant experience.

• Experience:Experience:Experience: At least 1-2 years of experience in a GMP-regulated environment, such as pharmaceuticals or biologics.

• Documentation Skills:Documentation Skills:Documentation Skills: Demonstrated experience reviewing GMP-regulated documents such as batch records, Standard Operating Procedures (SOPs), and quality investigations.
• Systems Proficiency:Systems Proficiency:Systems Proficiency: Strong attention to detail; proficiency with computer systems including Microsoft Suite, SAP, and Veeva.

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

• Direct experience in a quality assurance role reviewing and releasing batch records.
• In-depth knowledge of USDA and EU regulatory requirements for biological products.
• Experience with electronic quality management systems for deviations, change control, and CAPA.
• Strong technical writing skills for authoring or reviewing investigation reports.

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!