Quality Operations Specialist (Aseptic)

Elanco•Winslow, ME

About The Position

The Quality Operations Specialist (Aseptic) 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).

Requirements

B.S.in engineering, microbiology/biology, or equivalent discipline.
Minimum 5 years experience working in a regulated USDA and/or US/EU GMP manufacturing environment
Familiarity with applicable Global Regulatory, Quality and ISO standards such as FDA (Food and Drug Administration), EU (European Union) GMP, USDA (United States Department of Agriculture), and CFIA (Canadian Food Inspection Agency)

Nice To Haves

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.

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.