Sterility Assurance Specialist - Quality & Compliance

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

Job summary

Baxter is seeking a Quality Associate III in Round Lake, IL, to support Sterility Assurance. This role requires applying microbiology, engineering, and quality principles to aseptic processing, sterilization, and contamination control. You will work cross-functionally to investigate issues, perform risk assessments, and drive CAPA initiatives.

The position emphasizes independent technical execution and development toward Sterility Assurance expert status within a GMP manufacturing environment.

Qualifications

• Bachelor's degree in microbiology, biology, engineering, pharmaceutical sciences, or related field.
• 3-5 years of sterile pharmaceutical manufacturing experience.
• Experience supporting aseptic processing, sterilization, environmental monitoring.

Responsibilities

• Plan, execute, and document sterility assurance studies.
• Support sterilization and decontamination systems and cycle development.
• Assist aseptic processing and contamination control evaluation.
• Lead or support investigations, risk assessments, and CAPA.
• Analyze environmental monitoring and microbiological data.
• Develop qualification protocols for sterile equipment and processes.
• Collaborate cross-functionally with Quality, Manufacturing, Microbiology, Validation.
• Prepare GMP documentation and communicate technical findings.

Skills

Problem-solving

Technical writing

Data analysis

Communication skills

Collaboration

Education

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

3-5 years of sterile pharmaceutical manufacturing experience

Job description

Baxter is seeking a Quality Associate III in Round Lake, IL, to support Sterility Assurance. This role requires applying microbiology, engineering, and quality principles to aseptic processing, sterilization, and contamination control. You will work cross-functionally to investigate issues, perform risk assessments, and drive CAPA initiatives.

The position emphasizes independent technical execution and development toward Sterility Assurance expert status within a GMP manufacturing environment.