Quality Assurance Advisor, Sterility Assurance
Elanco
August 20, 2026
Remote
United States
Operations
Your Role: Quality Assurance Advisor, Sterility Assurance
The Network Level Sterility Assurance Advisor provides oversight and contributions to Sterility Assurance/Contamination Control Strategy deliverables within the Biotech network, ensuring manufacturing meets global procedures, GMP, regulatory expectations, and industry best practices. Acts as a subject matter expert and collaborates with production, QC, and TS/MS teams to improve site Sterility Assurance programs, including aseptic training/qualification, Aseptic Process Simulation (APS), contamination control, and Environmental Monitoring (EM).
Responsibilities:
- Provide technical/SME input for Process, Aseptic, Cleaning Validation, and Contamination Control Strategy programs; maintain lifecycle documentation.
- Collaborate with area owners and suppliers to finalize validation/qualification requirements for facilities, processes, equipment, and systems.
- Author and develop Elanco Functional Procedures (EFPs) for Contamination Control, sterile/aseptic processes, and disinfection validation plans.
- Troubleshoot, perform gap/risk assessments, support regulatory inspections, and conduct training.
- Oversee (re)validation/qualification for manufacturing, aseptic processing, media fills/holds, and sterilization cycles; support corrective actions (RCI and CAPA).
What You Need to Succeed (Minimum Qualifications):
- B.S. in engineering, microbiology/biology, or equivalent.
- 10+ years’ experience in parenteral/biological/vaccine manufacturing; environmental monitoring; aseptic processing; sterile gowning.
- Familiarity with global regulatory, quality, and ISO standards (FDA, EU GMP, USDA, CFIA).
What Will Give You the Competitive Edge (Preferred Qualifications):
- Master’s or PhD.
- Lean and six sigma experience.
- Sterile manufacturing risk assessments and remediation implementation.
- Strong organization, time management, attention to detail, and collaboration; ability to manage changing priorities.
Additional Information:
- Remote position with occasional travel (up to 30%).
The Network Level Sterility Assurance Advisor provides oversight and contributions to Sterility Assurance/Contamination Control Strategy deliverables within the Biotech network, ensuring manufacturing meets global procedures, GMP, regulatory expectations, and industry best practices. Acts as a subject matter expert and collaborates with production, QC, and TS/MS teams to improve site Sterility Assurance programs, including aseptic training/qualification, Aseptic Process Simulation (APS), contamination control, and Environmental Monitoring (EM).
Responsibilities:
- Provide technical/SME input for Process, Aseptic, Cleaning Validation, and Contamination Control Strategy programs; maintain lifecycle documentation.
- Collaborate with area owners and suppliers to finalize validation/qualification requirements for facilities, processes, equipment, and systems.
- Author and develop Elanco Functional Procedures (EFPs) for Contamination Control, sterile/aseptic processes, and disinfection validation plans.
- Troubleshoot, perform gap/risk assessments, support regulatory inspections, and conduct training.
- Oversee (re)validation/qualification for manufacturing, aseptic processing, media fills/holds, and sterilization cycles; support corrective actions (RCI and CAPA).
What You Need to Succeed (Minimum Qualifications):
- B.S. in engineering, microbiology/biology, or equivalent.
- 10+ years’ experience in parenteral/biological/vaccine manufacturing; environmental monitoring; aseptic processing; sterile gowning.
- Familiarity with global regulatory, quality, and ISO standards (FDA, EU GMP, USDA, CFIA).
What Will Give You the Competitive Edge (Preferred Qualifications):
- Master’s or PhD.
- Lean and six sigma experience.
- Sterile manufacturing risk assessments and remediation implementation.
- Strong organization, time management, attention to detail, and collaboration; ability to manage changing priorities.
Additional Information:
- Remote position with occasional travel (up to 30%).