Want to know if this job is worth applying to?
Fort Dodge, Iowa, United States
Onsite
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!
As the QA – Batch Release & Quality Oversight, you will be part of the Quality organization supporting vaccine manufacturing and product release activities at the Fort Dodge site. In this role, you will be responsible for ensuring regulatory compliance, providing quality oversight across manufacturing operations, and authorizing final product release to the U.S. market while driving continuous improvement and inspection readiness.
• Provide quality oversight to ensure manufacturing, sampling, and testing activities comply with regulatory requirements, outlines of production, and Elanco quality standards.
• Review and approve batch documentation, analytical data, deviations, change controls, and CAPAs to support final product release and submission to USDA for market authorization.
• Serve as a Quality and GMP Subject Matter Expert (SME), providing technical guidance, training, and support across Manufacturing, Quality, and other cross-functional teams.
• Support internal, corporate, and regulatory inspections, ensuring audit readiness, effective responses, and timely completion of corrective actions.
• Review and approve quality investigations, stability reports, validation protocols, SOPs, and risk assessments while championing continuous improvement initiatives across the site and network.
• Education: Bachelor's degree in biology, Chemistry, Biochemistry, Biopharmaceuticals, Engineering, or related scientific discipline.
• Experience: Minimum of 10 years of experience in a regulated pharmaceutical, biologics, or vaccine manufacturing environment.
• Top 2 skills: Deep knowledge of cGMP/GLP regulations and quality systems combined with strong cross-functional leadership and decision-making skills.
• Advanced degree (M.S., Ph.D., or equivalent) in a scientific or technical discipline.
• Experience with USDA biologics regulations, vaccine batch release, and product submission processes.
• Demonstrated experience reviewing and approving deviations, investigations, CAPAs, validation documentation, and stability reports.
• Proven ability to lead quality initiatives and drive continuous improvement in a regulated manufacturing environment.
• Strong technical writing, communication, and stakeholder management skills with the ability to influence across all organizational levels.
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.