Senior Sterility Assurance Specialist (QA)

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

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

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

You will plan, execute, document, and evaluate studies across aseptic processing, sterilization, and contamination control, while collaborating with cross-functional teams to sustain sterility programs. The role emphasizes investigations, risk assessments, data trending, and continuous improvement within a GMP environment; occasional off-shift work is

Qualifications

• Knowledge of aseptic processing and contamination control.
• Experience with sterilization/decontamination, environmental monitoring, and microbiological control.
• Ability to evaluate data and translate findings into recommendations.

Responsibilities

• Plan, execute, and document sterility assurance studies.
• Support sterilization/decontamination cycle development and qualification.
• Assist aseptic processing and contamination control improvements.
• Lead or support investigations, risk assessments and CAPA.
• Analyze environmental and microbiological data to identify trends and risks.
• Develop qualification protocols and validation support for equipment and processes.
• Contribute to corrective actions and sustained state monitoring.
• Collaborate with Quality, Manufacturing, Microbiology, Validation and Engineering.

Skills

Aseptic processing

Contamination control

Sterilization

Environmental monitoring

Microbiological control

Sterile process qualification

Education

Bachelor's degree in microbiology, biology, engineering, pharmaceutical sciences, or related field

Job description

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

You will plan, execute, document, and evaluate studies across aseptic processing, sterilization, and contamination control, while collaborating with cross-functional teams to sustain sterility programs. The role emphasizes investigations, risk assessments, data trending, and continuous improvement within a GMP environment; occasional off-shift work is