QC Microbiology Lab Lead - Aseptic Manufacturing

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

Benefits offered by this job

Discretionary bonuses

Comprehensive benefits package

Job summary

Baxter International Inc. seeks a QC Microbiology Laboratory Supervisor to oversee aseptic manufacturing support, including environmental monitoring, bioburden, endotoxin, sterility, and water testing. You will drive cGMP compliance and readiness for regulatory inspections.

You will lead laboratory staff, train, and develop personnel, and manage investigations with robust CAPAs. Strong data integrity and quality system experience are essential; some off-hours work may be required.

Qualifications

• Bachelor's degree in Microbiology, Biology, or related life science discipline.
• 5-7 years of QC Microbiology experience in pharma, biologics, medical device, or aseptic manufacturing environment.
• Minimum 2 years of supervisory or technical leadership experience preferred.
• Experience supporting FDA inspections, customer audits, and regulatory compliance activities preferred.

Responsibilities

• Provide microbiological oversight for aseptic manufacturing operations, including environmental monitoring programs, contamination control initiatives, and process monitoring activities.
• Train, certify, coach, and develop laboratory personnel; manage performance evaluations and corrective counseling in a timely manner.
• Ensure compliance with ALCOA+ principles, data integrity requirements, electronic records requirements, and applicable laboratory procedures.
• Lead microbiological investigations involving environmental monitoring excursions, sterility failures, bioburdens, endotoxin results, and CAPAs; use root cause analysis andQuality Risk Management.
• Assist in implementing quality and regulatory requirements (FDA, GLP, QSR, cGMP, USP) and ensure SOPs are followed.
• Act as primary lab representative during FDA, MOH, corporate, customer, and third-party audits; support audit readiness and corrective actions.
• Review and trend microbiological data to identify risks and opportunities for continuous improvement; communicate findings to site leadership.
• Prepare, review, and revise standard operating procedures and specifications.
• Ensure equipment maintenance and calibration are performed on schedule.
• Maintain laboratory documentation and ensure inspection readiness.

Skills

Supervisory

Communication

cGMP/FDA knowledge

Quality systems

Data trending

Environmental monitoring

Education

Bachelor's degree in Microbiology

5-7 years QC Microbiology experience

Supervisory experience

FDA inspections experience

Tools

LIMS

Electronic quality management systems

Job description

Baxter International Inc. seeks a QC Microbiology Laboratory Supervisor to oversee aseptic manufacturing support, including environmental monitoring, bioburden, endotoxin, sterility, and water testing. You will drive cGMP compliance and readiness for regulatory inspections.

You will lead laboratory staff, train, and develop personnel, and manage investigations with robust CAPAs. Strong data integrity and quality system experience are essential; some off-hours work may be required.