Quality Operations Specialist (Aseptic)

About the role

The Quality Operations Specialist (Aseptic) at Elanco is responsible for providing critical oversight and direct contributions to Sterility Assurance/Contamination Control Strategy deliverables within the Biotech network. This role ensures manufacturing operations meet global procedures, GMP, regulatory expectations, and industry best practices.

Responsibilities

• Provide technical and SME input for various programs including Process, Aseptic, Cleaning Validation, and Contamination Control Strategy, while maintaining lifecycle documentation.
• Collaborate with area owners and suppliers to finalize validation/qualification requirements for facilities, processes, equipment, and systems, ensuring adherence to all relevant policies and regulations.
• Author and develop Elanco Functional Procedures (EFPs) for Contamination Control, sterile/aseptic processes, cleaning, and disinfection validation plans.
• Aid in troubleshooting, performing gap/risk assessments, providing support for regulatory inspections, and conducting necessary training.
• Oversee the execution of (re)validation/qualification activities for manufacturing, aseptic processing, media fills, media holds, and sterilization cycles, and support corrective actions including RCI and CAPA.

Requirements

• Bachelor’s degree in engineering, microbiology/biology, or a related field.
• Minimum 5 years of experience working in a regulated USDA and/or US/EU GMP manufacturing environment.

Preferred Qualifications

• Experience with parenteral, biological, or vaccine manufacturing operations, environmental monitoring, aseptic processing, and sterile gowning.
• Experience with sterile manufacturing risk assessments and remediations implementation.
• Lean manufacturing and six sigma experience.
• Proven organization and time management skills to meet time sensitive deadlines, attention to detail, and collaboration in a team-based environment are essential.
• Ability to work in a fast-paced and dynamic environment with changing priorities, and flexibility to support multiple projects simultaneously.

Benefits and Perks

Elanco offers a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Highlights include: Multiple relocation packages for eligible positions, two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO), 8-week parental leave, 9 Employee Resource Groups, annual bonus offering up to 6% 401K matching, and more.