Sr. Associate, Quality Assurance Validation

Sr. Associate, Quality Assurance Validation – Elwood, Kansas (Onsite)

• 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.

• 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).

• 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 (