Quality Associate III, Sterility Assurance

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At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

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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 process simulation, sterilization/decontamination, and other sterility assurance data to identify adverse trends, recurring events, emerging contamination risks, and opportunities for improvement.
• Qualification & Validation Support: Develop and execute qualification protocols and technical assessments supporting sterile manufacturing equipment and processes. Evaluate study results, deviations, atypical findings, acceptance criteria failures, and qualification data to support scientifically justified conclusions and recommendations.
• CAPA & Remediation Execution: Support implementation of corrective and preventive actions and Sterility Assurance remediation initiatives. Execute assigned technical workstreams, studies, data reviews, effectiveness assessments, procedural improvements, and sustained state monitoring activities.

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