Advisor-Quality Assurance
On-site · Fort Dodge, Iowa, United States
Job Summary
Quality Assurance Advisor at Elanco Fort Dodge site; responsible for developing, implementing, maintaining, and continuously improving the Quality Management System, ensuring compliance with regulatory requirements and corporate quality standards while supporting operational excellence and inspection readiness. Owns and executes Self-Inspections, Quality Governance, Quality Systems, Quality Projects, and Computer System Quality Assurance. Requires a Bachelor’s Degree in Engineering, Science, or related field with at least 5 years of technical/quality experience in Biotech or Pharmaceutical industries; MS preferred. Strong knowledge of FDA/EU GMP/USDA expectations, quality principles, statistics, and technical writing; demonstrated ability to work in a team and lead without authority.
Required 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 Global Regulatory, Quality and ISO standards such as FDA, EU GMP, and USDA
- Proven quality assurance experience in a regulated environment
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