Quality Assurance Associate - Sterility

Role Summary

The Sterility Assurance Associate provides critical oversight and direct contributions to Sterility Assurance/Contamination Control Strategy deliverables within the Biotech network, ensuring manufacturing operations meet global procedures, GMP, regulatory expectations, and industry best practices. Acting as a subject matter expert, this role involves cross-functional collaboration with production, QC, and TS/MS teams. The primary goal is to improve site Sterility Assurance programs, including aseptic training/qualification, Aseptic Process Simulation (APS), and Environmental Monitoring (EM).

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.
• Assist in troubleshooting, performing gap/risk assessments, providing support for regulatory inspections, and conducting necessary training.
• Provide oversight during 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.

Qualifications

• Required: B.S. in engineering, microbiology/biology, or equivalent discipline.
• Required: Familiarity with applicable Global Regulatory, Quality and ISO standards such as FDA, EU GMP, USDA, and CFIA.
• Preferred: Experience with parenteral, biological, or vaccine manufacturing operations, environmental monitoring, aseptic processing, and sterile gowning.
• Preferred: Experience with sterile manufacturing risk assessments and remediations implementation.
• Preferred: Lean manufacturing and Six Sigma experience.
• Preferred: Proven organization and time management skills to meet time sensitive deadlines, attention to detail, and collaboration in a team-based environment.
• Preferred: Ability to work in a fast-paced and dynamic environment with changing priorities, and flexibility to support multiple projects simultaneously.