Quality Assurance Associate

Elanco; Fort Dodge (IA); On-site; USD 55,000 - 75,000; Full time

Job summary

Elanco is seeking a Quality Associate to provide critical QA support for the Release Group and Process Team. You will review developmental and revised batch records and ensure compliance with USDA, FDA, and EU regulations.

This role includes on-the-floor QA guidance, deviation investigations, and support for audits. This entry-level to mid-level QA position requires a scientific degree or equivalent experience, attention to detail, and proficiency with SAP and Veeva.

Qualifications

• GMP-regulated environment experience
• Documentation review of batch records and quality systems
• Strong attention to detail and accuracy
• Proficiency with SAP and Veeva systems
• Experience with SOPs and quality investigations
• Good written and oral communication

Responsibilities

• Review and approve batch records and technical documentation for compliance.
• Provide on-the-floor QA support to production and QA Release groups.
• Assist with deviation investigations and CAPAs.
• Support audits and regulatory inspections as needed.
• Execute release decisions in SAP for product movement.

Job description

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: Quality Associate

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.

Your Responsibilities

• 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).

What You Need to Succeed (minimum qualifications)

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

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

Documentation Skills: Demonstrated experience reviewing GMP-regulated documents such as batch records, Standard Operating Procedures (SOPs), and quality investigations.

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.

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.

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer.

For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose CSR framework - all to advance the health of animals, people and the planet. Learn more at www.elanco.com.