QC Microbiology Lab Supervisor — Aseptic & Compliance

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

Benefits offered by this job

Discretionary bonuses

Comprehensive benefits

Job summary

Baxter International Inc. seeks a Lead QC Microbiology role to oversee aseptic manufacturing microbiology, environmental monitoring, bioburden, and sterility testing. You will lead investigations, drive CAPAs, and ensure readiness for FDA inspections while coaching lab staff.

The position requires a Bachelor's in Microbiology or related field with 5–7 years of QC microbiology experience and at least 2 years of supervisory leadership. Strong data trending, LIMS, and GMP knowledge are essential.

Qualifications

• Bachelor's degree in Microbiology or related field.
• 5-7 years QC Microbiology in pharma/biologics/aseptic manufacturing.
• Minimum 2 years of supervisory or leadership experience.

Responsibilities

• Provide microbiological oversight for aseptic manufacturing and monitoring programs.
• Lead investigations and manage CAPAs with risk-based analyses.
• Ensure regulatory compliance with FDA, GMP, USP; prepare for audits.
• Train and develop personnel; manage performance evaluations.
• Maintain environmental monitoring, sterility, and bioburden testing programs.
• Review data trends and communicate risks to site leadership.

Skills

Supervisory skills

Regulatory compliance

Communication

Data trending

LIMS experience

Environmental monitoring

Aseptic processing knowledge

Physical capability

Education

Bachelor's in Microbiology or related

5-7 years QC Microbiology experience

2+ years supervisory experience

Tools

LIMS

Data trending tools

Electronic quality systems

Job description

Baxter International Inc. seeks a Lead QC Microbiology role to oversee aseptic manufacturing microbiology, environmental monitoring, bioburden, and sterility testing. You will lead investigations, drive CAPAs, and ensure readiness for FDA inspections while coaching lab staff.

The position requires a Bachelor's in Microbiology or related field with 5–7 years of QC microbiology experience and at least 2 years of supervisory leadership. Strong data trending, LIMS, and GMP knowledge are essential.