QC Microbiology Lab Lead – Aseptic Manufacturing

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

Benefits offered by this job

Discretionary bonuses

Job summary

Baxter is seeking a QC Microbiology Laboratory Supervisor to lead aseptic manufacturing microbiology programs in Round Lake Beach, IL. You will oversee environmental monitoring, bioburden, endotoxin, sterility, and water testing, ensuring compliance with cGMP, FDA, USP, and applicable regulations.

You will coach staff, drive CAPAs, manage investigations, and prepare for audits. A Bachelor's in Microbiology and 5–7 years in QC Microbiology are required.

Qualifications

• Bachelor's degree in Microbiology, Biology, or related life science.
• 5–7 years of QC Microbiology experience in a pharmaceutical, biologics, medical device, or aseptic manufacturing environment supporting environmental monitoring, sterility assurance, and microbiological testing programs.
• Experience supporting FDA inspections, customer audits, and regulatory compliance activities is preferred.

Responsibilities

• Provide microbiological oversight for aseptic manufacturing operations, including environmental monitoring programs and contamination control initiatives.
• Train, certify, coach, and develop laboratory personnel; manage performance evaluations and corrective counseling.
• Ensure ALCOA+ data integrity and electronic records compliance; maintain SOPs and specifications.
• Lead microbiological investigations involving environmental monitoring excursions, sterility failures, bioburden excursions, endotoxin results, and nonconformances; conduct risk assessments.
• Act as primary laboratory representative during FDA audits and inspections; support audit preparation and corrective actions.
• Review and trend microbiological data to identify risks and communicate findings to site leadership.
• Ensure equipment maintenance and calibration on schedule; maintain laboratory documentation.
• Maintain inspection readiness through proper procedures, training, and timely closure of records.

Skills

Supervisory skills

Interpersonal skills

Communication

Regulatory knowledge

Data analysis

Problem solving

Education

Bachelor's degree in Microbiology

5–7 years QC Microbiology experience

2+ years supervision

Tools

LIMS

Data trending tools

Job description

Baxter is seeking a QC Microbiology Laboratory Supervisor to lead aseptic manufacturing microbiology programs in Round Lake Beach, IL. You will oversee environmental monitoring, bioburden, endotoxin, sterility, and water testing, ensuring compliance with cGMP, FDA, USP, and applicable regulations.

You will coach staff, drive CAPAs, manage investigations, and prepare for audits. A Bachelor's in Microbiology and 5–7 years in QC Microbiology are required.