Self-Inspection and Audits: Implement and maintain the site self-inspection program, lead self-inspections, train auditors, and participate in external audits
Quality Governance: Develop and maintain the Site Quality Plan and Site Master File, oversee Quality Lead Team and/or Change Review Board as needed and report on the overall state of control to the senior leadership team
Quality Systems: Performs periodic reviews and document updates, owns change control action items and CAPAs toward timely completion
Quality Projects: Project management of Quality initiatives to improve the site Quality Management System
Computer System Quality Assurance: Provides GxP oversight for computerized systems
What You Need to Succeed (minimum qualifications):
Bachelor's Degree in Engineering, Science, or related field with a minimum of 5 years technical and/or quality experience in Biotech or Pharmaceutical industry.
Familiarity with applicable Global Regulatory, Quality and ISO standards such as FDA (Food and Drug Administration), EU (European Union), GMP, and USDA (United States Department of Agriculture)
Proven quality assurance experience in a regulated environment.
What Will Give You the Competitive Edge (preferred qualifications):
M.S degree is preferred.
Root cause analysis and troubleshooting skills.
Strong knowledge of statistics, databases, and quality principles.
Demonstrate strong oral, written, and interpersonal skills.
Strong ability to work on a team and lead without authority.
Technical writing skills.
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
Benefits
Health insuranceVision insurance
Additional Information
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!
Grow your career internally at Elanco, our best talent comes from within!
Your Role: Quality Assurance Advisor
The Quality Assurance Advisor is responsible for contributing to the development, implementation, maintenance, and continuous improvement of the Quality Management System at the Elanco Fort Dodge site. The position responsibilities include ensuring compliance with regulatory requirements and corporate quality standards while supporting operational excellence and inspection readiness. The position focuses on owning and executing tasks related to Self-Inspections, Quality Governance, Quality Systems, Quality Projects, and Computer System Quality Assurance.
Elanco · Fort Dodge, IA