Sterility Assurance Specialist – Quality & Compliance

Baxter International; Round Lake (IL); On-site; USD 80,000 - 120,000; Full time

Job summary

Baxter is seeking a Quality Associate III, Sterility Assurance at its Round Lake, IL facility. You will provide technical execution and support for sterility assurance programs across aseptic processing, sterilization, and contamination control, partnering with Quality, Manufacturing, Microbiology, Validation, Engineering, and Maintenance.

The role emphasizes investigations, data analysis, risk assessment, and CAPA with opportunities to develop SME expertise in sterility assurance within a GMP

Qualifications

• Bachelor's degree in microbiology, biology, engineering, pharmaceutical sciences, or related scientific/technical discipline.
• 3-5 years of relevant experience in sterile pharmaceutical manufacturing, Quality, Validation, Microbiology, Engineering, Sterility Assurance, or a related technical discipline.
• Experience supporting aseptic processing, sterilization/decontamination, environmental monitoring, contamination control, or sterile process qualification preferred.

Responsibilities

• Plan, develop, execute, and document sterility assurance studies supporting aseptic processing, sterilization, decontamination, contamination control, qualification, process characterization, and continuous improvement activities.
• 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.
• 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.
• Lead or support sterility assurance and microbiology-related investigations, deviation assessments, cause evaluations, product/process impact assessments, and quality risk assessments.
• 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.
• Develop and execute qualification protocols and technical assessments supporting sterile manufacturing equipment and processes.
• Support implementation of corrective and preventive actions and Sterility Assurance remediation initiatives.
• Prepare clear, accurate, and scientifically defensible protocols, reports, investigations, risk assessments, technical assessments, procedures, data summaries, and other GMP documentation.
• Partner with Quality, Manufacturing, Microbiology, Validation, Engineering, Maintenance, and other functions to resolve sterility assurance issues and execute improvement activities.

Education

Bachelor's degree in microbiology, biology, engineering, pharmaceutical sciences, or related scientific/technical discipline

Job description

Baxter is seeking a Quality Associate III, Sterility Assurance at its Round Lake, IL facility. You will provide technical execution and support for sterility assurance programs across aseptic processing, sterilization, and contamination control, partnering with Quality, Manufacturing, Microbiology, Validation, Engineering, and Maintenance.

The role emphasizes investigations, data analysis, risk assessment, and CAPA with opportunities to develop SME expertise in sterility assurance within a GMP