Sr. Associate, Quality Assurance Validation
Elanco
5 hours ago
On-site
Elwood, KS
Operations
Your Responsibilities:
- Provide Quality oversight for capital projects by serving as the QA representative throughout the project lifecycle (design through qualification and validation) for facilities, utilities, equipment, and computerized systems used in mAb manufacturing.
- Review and approve validation lifecycle documentation, including User Requirements, Design Qualifications, FAT/SAT, IQ/OQ/PQ protocols, reports, procedures, and periodic reviews; guide qualification and validation strategies to ensure compliance and consistency.
- Support and oversee computer system validation (CSV) activities and contribute to improving site data integrity processes; drive continuous improvement and standardization of equipment/system lifecycle documentation.
- Ensure compliance with cGMP and regulatory requirements through Quality review/oversight of site documentation; support internal audits and regulatory inspections; promote a “Safety First and Quality Always” culture.
What You Need to Succeed (minimum qualifications):
- Bachelor’s degree in a science or engineering discipline.
- 5+ years of experience in quality, engineering, or validation roles within biologics or pharmaceutical industries, including equipment lifecycle management and CSV.
- Strong organizational and communication skills with high attention to detail; collaborate effectively across cross-functional teams and multiple organizational levels; proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).
What will give you a competitive edge (preferred qualifications):
- Materials management experience in USDA, FDA, or EMA regulated environments.
- Experience leading 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:
- Multiple relocation packages (eligible roles)
- 8-week parental leave
- Annual bonus offering
- Up to 6% 401K matching
Application instructions:
- Don’t meet every requirement? If you think you may be a fit, apply.
- Provide Quality oversight for capital projects by serving as the QA representative throughout the project lifecycle (design through qualification and validation) for facilities, utilities, equipment, and computerized systems used in mAb manufacturing.
- Review and approve validation lifecycle documentation, including User Requirements, Design Qualifications, FAT/SAT, IQ/OQ/PQ protocols, reports, procedures, and periodic reviews; guide qualification and validation strategies to ensure compliance and consistency.
- Support and oversee computer system validation (CSV) activities and contribute to improving site data integrity processes; drive continuous improvement and standardization of equipment/system lifecycle documentation.
- Ensure compliance with cGMP and regulatory requirements through Quality review/oversight of site documentation; support internal audits and regulatory inspections; promote a “Safety First and Quality Always” culture.
What You Need to Succeed (minimum qualifications):
- Bachelor’s degree in a science or engineering discipline.
- 5+ years of experience in quality, engineering, or validation roles within biologics or pharmaceutical industries, including equipment lifecycle management and CSV.
- Strong organizational and communication skills with high attention to detail; collaborate effectively across cross-functional teams and multiple organizational levels; proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).
What will give you a competitive edge (preferred qualifications):
- Materials management experience in USDA, FDA, or EMA regulated environments.
- Experience leading 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:
- Multiple relocation packages (eligible roles)
- 8-week parental leave
- Annual bonus offering
- Up to 6% 401K matching
Application instructions:
- Don’t meet every requirement? If you think you may be a fit, apply.