Quality Assurance Advisor-Systems & Compliance
Elanco
June 27, 2026
On-site
Fort Dodge, IA
Operations
Your Role: Quality Assurance Advisor—Compliance & Systems
The Quality Assurance Advisor contributes to the development, implementation, maintenance, and continuous improvement of the Quality Management System at the Elanco Fort Dodge site. Ensures compliance with regulatory requirements and corporate quality standards while supporting operational excellence and inspection readiness. Owns and executes tasks related to Self-Inspections, Quality Governance, Quality Systems, Quality Projects, and Computer System Quality Assurance.
Your Responsibilities:
- 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; report control status to senior leadership
- Quality Systems: Perform periodic reviews and document updates; own 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: Provide GxP oversight for computerized systems
What You Need to Succeed (minimum qualifications):
- Bachelor’s Degree in Engineering/Science/related field with at least 5 years technical and/or quality experience in Biotech or Pharmaceutical industry
- Familiarity with global regulatory, quality, and ISO standards (e.g., FDA, EU, GMP, USDA)
- Proven quality assurance experience in a regulated environment
What Will Give You the Competitive Edge (preferred qualifications):
- M.S. preferred
- Root cause analysis and troubleshooting skills
- Strong knowledge of statistics, databases, and quality principles
- Strong oral, written, and interpersonal skills
- Ability to work on a team and lead without authority
- Technical writing skills
The Quality Assurance Advisor contributes to the development, implementation, maintenance, and continuous improvement of the Quality Management System at the Elanco Fort Dodge site. Ensures compliance with regulatory requirements and corporate quality standards while supporting operational excellence and inspection readiness. Owns and executes tasks related to Self-Inspections, Quality Governance, Quality Systems, Quality Projects, and Computer System Quality Assurance.
Your Responsibilities:
- 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; report control status to senior leadership
- Quality Systems: Perform periodic reviews and document updates; own 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: Provide GxP oversight for computerized systems
What You Need to Succeed (minimum qualifications):
- Bachelor’s Degree in Engineering/Science/related field with at least 5 years technical and/or quality experience in Biotech or Pharmaceutical industry
- Familiarity with global regulatory, quality, and ISO standards (e.g., FDA, EU, GMP, USDA)
- Proven quality assurance experience in a regulated environment
What Will Give You the Competitive Edge (preferred qualifications):
- M.S. preferred
- Root cause analysis and troubleshooting skills
- Strong knowledge of statistics, databases, and quality principles
- Strong oral, written, and interpersonal skills
- Ability to work on a team and lead without authority
- Technical writing skills