Sterility Assurance Quality Specialist III

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

Benefits offered by this job

Health and dental coverage

Paid time off 20–35 days

401(k) with company match

Employee stock purchase plan (ESPP)

Flexible Spending Accounts

Job summary

Baxter International Inc. is seeking a Quality Associate III, Sterility Assurance in Round Lake, IL.

You will support QC Sterility Assurance operations, plan and execute studies, and collaborate across Sterility Assurance, Quality, Manufacturing, and Microbiology to sustain aseptic processing excellence. You will apply microbiology and quality principles to evaluate performance, investigate adverse trends, and drive improvements in contamination control and environmental monitoring.

Qualifications

• Requires Bachelor's degree in a scientific/technical discipline.
• 3–5 years of relevant experience in sterile pharmaceutical manufacturing or related fields.
• Experience supporting aseptic processing, sterilization/decontamination, environmental monitoring, contamination control, or sterile process qualification is preferred.

Responsibilities

• Plan, develop, execute, and document sterility assurance studies.
• Support sterilization and decontamination activities including cycle development and qualification.
• Assist aseptic processing and contamination control system improvements.
• Lead or support investigations, risk assessments, and CAPA with data reviews.
• Analyze environmental and microbiological data to identify trends and risks.
• Develop qualification protocols and assessments for sterile equipment and processes.
• Support remediation and continuous improvement initiatives in sterility programs.
• Communicate findings and recommendations across Quality, Manufacturing, Engineering, and Microbiology functions.

Skills

Aseptic processing

Contamination control

Sterilization/decontamination

Environmental monitoring

Microbiological control

Sterility Assurance

Technical writing

Data analysis

Problem solving

Communication & collaboration

Education

Bachelor's degree in microbiology/biology/engineering/pharmaceutical sciences

Job description

Baxter International Inc. is seeking a Quality Associate III, Sterility Assurance in Round Lake, IL.

You will support QC Sterility Assurance operations, plan and execute studies, and collaborate across Sterility Assurance, Quality, Manufacturing, and Microbiology to sustain aseptic processing excellence. You will apply microbiology and quality principles to evaluate performance, investigate adverse trends, and drive improvements in contamination control and environmental monitoring.