Sr. Associate, Quality Assurance Validation
Elanco
August 21, 2026
On-site
Elwood, KS
Operations
Your Role: Sr. Associate, Quality Assurance Validation
Responsibilities:
- Serve as the QA representative for capital projects across design, commissioning, qualification, and validation for facilities, utilities, equipment, and computerized systems used in mAb manufacturing.
- Review and approve validation lifecycle documentation (User Requirements, Design Qualifications, FAT/SAT, IQ/OQ/PQ protocols, reports, procedures, periodic reviews) and guide qualification/validation strategies.
- Support/oversee computer system validation (CSV) and improve site data integrity processes; standardize equipment/system lifecycle documentation.
- Ensure compliance with cGMP and regulatory requirements via QA review/oversight; support internal audits and regulatory inspections; promote “Safety First and Quality Always.”
Minimum Qualifications:
- Bachelor’s degree in a science or engineering discipline.
- 5+ years in quality, engineering, or validation roles in biologics/pharmaceuticals; experience with equipment lifecycle management and CSV.
- Strong organization/communication, high attention to detail; collaboration across cross-functional teams; proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).
Preferred Qualifications:
- Materials management experience in USDA/FDA/EMA-regulated environments; led cross-functional teams/projects.
- Experience with SAP, JMP, and Veeva Vault.
- Working knowledge of VICH, USDA, and/or EU GMP regulations for veterinary biologics.
Benefits (highlights): Multiple relocation packages; 8-week parental leave; 9 Employee Resource Groups; annual bonus offering; up to 6% 401(k) matching.
Application Instruction:
- If you don’t meet every requirement, you’re still encouraged to apply.
Responsibilities:
- Serve as the QA representative for capital projects across design, commissioning, qualification, and validation for facilities, utilities, equipment, and computerized systems used in mAb manufacturing.
- Review and approve validation lifecycle documentation (User Requirements, Design Qualifications, FAT/SAT, IQ/OQ/PQ protocols, reports, procedures, periodic reviews) and guide qualification/validation strategies.
- Support/oversee computer system validation (CSV) and improve site data integrity processes; standardize equipment/system lifecycle documentation.
- Ensure compliance with cGMP and regulatory requirements via QA review/oversight; support internal audits and regulatory inspections; promote “Safety First and Quality Always.”
Minimum Qualifications:
- Bachelor’s degree in a science or engineering discipline.
- 5+ years in quality, engineering, or validation roles in biologics/pharmaceuticals; experience with equipment lifecycle management and CSV.
- Strong organization/communication, high attention to detail; collaboration across cross-functional teams; proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).
Preferred Qualifications:
- Materials management experience in USDA/FDA/EMA-regulated environments; led cross-functional teams/projects.
- Experience with SAP, JMP, and Veeva Vault.
- Working knowledge of VICH, USDA, and/or EU GMP regulations for veterinary biologics.
Benefits (highlights): Multiple relocation packages; 8-week parental leave; 9 Employee Resource Groups; annual bonus offering; up to 6% 401(k) matching.
Application Instruction:
- If you don’t meet every requirement, you’re still encouraged to apply.