Elanco
Advisor, Quality Assurance
Fort Dodge, IA
Sponsorship not specifiedDetected 28 days ago
ComplianceStakeholder ManagementGMPLeadershipCommunicationWriting
About the role
- QA Advisor - Batch Release & Quality Oversight
- 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.
Responsibilities
- 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.
Requirements
- Bachelor's degree in biology, Chemistry, Biochemistry, Biopharmaceuticals, Engineering, or related scientific discipline.
- Minimum of 10 years of experience in a regulated pharmaceutical, biologics, or vaccine manufacturing environment.
- What You Need to Succeed (minimum qualifications):
- Top 2 skills: Deep knowledge of cGMP/GLP regulations and quality systems combined with strong cross-functional leadership and decision-making skills.
Skills
- Deep knowledge of cGMP/GLP regulations and quality systems combined with strong cross-functional leadership and decision-making skills.
- What Will Give You a Competitive Edge (preferred qualifications):
- 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.
- Strong technical writing, communication, and stakeholder management skills with the ability to influence across all organizational levels.
- These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions.
- All decisions involve a human reviewer.
Benefits
- 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.
- Education: Bachelor's degree in biology, Chemistry, Biochemistry, Biopharmaceuticals, Engineering, or related scientific discipline.
Company info
- At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.
- 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.
This listing is sourced directly from Elanco's careers page and normalized into a canonical job model.