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Summary: Sterility is critical to patient safety, and maintaining it requires expertise, vigilance, and a commitment to quality. As a Quality Associate III, Sterility Assurance at Baxter, you will support QC Sterility Assurance operations at Baxter's manufacturing facility in Round Lake, IL. In this role, you will provide technical and execution support for sterility assurance and contamination control programs that support sterile pharmaceutical manufacturing operations. You will be responsible for planning, executing, documenting, and evaluating technical studies, investigations, risk assessments, qualification activities, data trending, and continuous improvement initiatives related to aseptic processing, sterilization and decontamination, environmental monitoring, microbiological control, and contamination control.
You will apply scientific, engineering, microbiological, and quality principles to evaluate process performance and contamination risk. You will support investigations of atypical conditions and adverse trends while developing technically sound conclusions and recommendations. Working cross-functionally with Sterility Assurance, Quality, Manufacturing, Microbiology, Validation, Engineering, and Maintenance teams, you will help execute and sustain site sterility assurance programs. This position is primarily an individual contributor role, providing independent technical execution while developing expertise as a Sterility Assurance subject matter expert.
Essential Duties and Responsibilities:
Sterility Assurance Study Execution : Plan, develop, execute, and document sterility assurance studies supporting aseptic processing, sterilization, decontamination, contamination control, qualification, process characterization, and continuous improvement activities. Develop protocols, sampling plans, acceptance criteria, data summaries, technical reports, and study conclusions.
Sterilization & Decontamination : Execute and support technical activities associated with sterilization and decontamination systems, including cycle development and characterization, qualification/requalification, biological indicator studies, chemical indicators, process parameter evaluation, cycle performance assessment, and investigation of atypical qualification results.
Aseptic Processing & Contamination Control : Support evaluation and improvement of aseptic processing and contamination control systems, including personnel and material flow, interventions, equipment and facility design, cleaning and decontamination practices, environmental monitoring, contamination pathways, and implementation of risk reduction measures.
Investigations, Risk Assessment & CAPA : Lead or support sterility assurance and microbiology-related investigations, deviation assessments, cause evaluations, product/process impact assessments, and quality risk assessments. Evaluate process, equipment, microbiological, environmental, qualification, and historical data to identify potential causes, contributing factors, trends, and appropriate corrective or preventive actions.
Environmental & Microbiological Data Analysis : Analyze and trend environmental monitoring, biological indicator, qualification, aseptic…