QC Microbiology Lab Supervisor: Aseptic Compliance Lead

Baxter International Inc.; Round Lake (IL); On-site; USD 80,000 - 110,000; Full time

Job summary

Baxter International Inc. is seeking a leader for the QC Microbiology Laboratory to supervise environmental monitoring, bioburden, endotoxin, sterility, and water testing while ensuring cGMP, FDA, USP compliance.

You will lead investigations, support regulatory inspections and audits, and drive CAPAs with robust data trends. The role requires 5–7 years in QC Microbiology with supervisory experience, strong communication, and ability to lift up to 50 pounds.

Qualifications

• Bachelor’s degree in Microbiology, Biology, or related life science discipline.
• Minimum 5-7 years of QC Microbiology experience in pharma/biologics/aseptic manufacturing.
• Minimum 2 years of supervisory or technical leadership experience preferred.
• Experience supporting environmental monitoring, sterility testing, bioburden, endotoxin, water monitoring, and microbiological investigations.
• Experience supporting FDA inspections, customer audits, and regulatory compliance.

Responsibilities

• Provide microbiological oversight for aseptic manufacturing operations and monitoring programs.
• Escalate risks and align goals with management.
• Train, certify, and develop laboratory personnel; manage performance evaluations and counseling.
• Ensure compliance with ALCOA+, data integrity, and SOPs.
• Lead microbiological investigations and CAPAs with root cause analysis.
• Assist in implementing FDA/GLP/QSR/cGMP/USP guidelines.
• Support audits, inspection readiness, and corrective actions.
• Review and trend data; communicate microbiological risks to site leadership.
• Prepare, review, and revise SOPs and specifications.

Skills

Supervisory skills

Interpersonal skills

USP knowledge

FDA inspections experience

Environmental monitoring

Contamination control

Microbiological risk assessment

Data trending tools

Cross-functional communication

Lifting up to 50 lbs

Education

Bachelor's degree in Microbiology

Tools

LIMS

Electronic quality management systems

Job description

Baxter International Inc. is seeking a leader for the QC Microbiology Laboratory to supervise environmental monitoring, bioburden, endotoxin, sterility, and water testing while ensuring cGMP, FDA, USP compliance.

You will lead investigations, support regulatory inspections and audits, and drive CAPAs with robust data trends. The role requires 5–7 years in QC Microbiology with supervisory experience, strong communication, and ability to lift up to 50 pounds.