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Sr. Associate, Quality Assurance ValidationElanco Tiergesundheit AG • Wathena, Kansas, United States
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Sr. Associate, Quality Assurance Validation

Elanco Tiergesundheit AG
  • US
    Wathena, Kansas, United States
  • US
    Wathena, Kansas, United States
Jetzt Bewerben

Über

Sr. Associate, Quality Assurance Validation – Elwood, Kansas (Onsite) Responsibilities Provide Quality oversight for capital projects by actively participating as the QA representative throughout the project lifecycle (design through qualification and validation). Support design, engineering, commissioning, and qualification of facilities, utilities, equipment, and computerized systems used in monoclonal antibody manufacturing. Review and approve validation lifecycle documentation, including User Requirements, Design Qualifications, FAT/SAT, IQ/OQ/PQ protocols, reports, procedures, and periodic reviews. Provide guidance on qualification and validation strategies to engineering and quality teams to ensure compliance and consistency. Support and oversee computer system validation (CSV) activities and contribute to maintaining and improving data integrity processes across the site. Drive continuous improvement and standardization of equipment and system lifecycle documentation aligned with Elanco operational standards. Ensure compliance with cGMP and regulatory requirements by performing Quality review and oversight of site documentation. Support internal audits and regulatory inspections as needed, promoting a “Safety First and Quality Always” culture across all activities. Minimum Qualifications Bachelor’s degree in a science or engineering discipline. 5+ years of experience in quality, engineering, or validation roles within the biologics or pharmaceutical industry. Experience in equipment lifecycle management and computer system validation (CSV). Strong organizational and communication skills with high attention to detail. Ability to collaborate effectively across cross‑functional teams and multiple organizational levels. Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook). Preferred Qualifications Experience in materials management within USDA, FDA, or EMA regulated environments. Demonstrated success leading cross‑functional teams or projects. Experience with SAP, JMP, and Veeva Vault systems. Working knowledge of VICH, USDA, and/or EU GMP regulations for veterinary biologics. Location: Elwood, Kansas (Onsite). Day shift position. Weekend or evening work may occasionally be required to support operations. Minimal travel required ( Benefits Multiple relocation packages for eligible roles 8‑week parental leave 9 Employee Resource Groups Annual bonus offering up to 6% 401(k) matching 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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  • Wathena, Kansas, United States

Sprachkenntnisse

  • English
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