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Advisor-Quality Assurance

Elanco Tiergesundheit AG
  • US
    Fort Dodge, Iowa, United States
  • US
    Fort Dodge, Iowa, United States

Über

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. Responsibilities Implement and maintain the site self‑inspection program, lead self‑inspections, train auditors, and participate in external audits. Develop and maintain the Site Quality Plan and Site Master File, oversee the Quality Lead Team and/or Change Review Board as needed, and report on the overall state of control to the senior leadership team. Perform periodic reviews and document updates, own change‑control action items and CAPAs toward timely completion. Project‑manage Quality initiatives to improve the site Quality Management System. Provide GxP oversight for computerized systems. Minimum Qualifications Bachelor’s Degree in Engineering, Science, or a related field. Minimum of 5 years of technical and/or quality experience in the biotech or pharmaceutical industry. Familiarity with applicable global regulatory, quality, and ISO standards such as FDA, EU, GMP, and USDA. Proven quality assurance experience in a regulated environment. Preferred Qualifications Master’s degree is preferred. Root cause analysis and troubleshooting skills. Strong knowledge of statistics, databases, and quality principles. 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.
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  • Fort Dodge, Iowa, United States

Sprachkenntnisse

  • English
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