QC Microbiology Lab Lead – Aseptic & Compliance

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

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

Baxter International Inc. in Round Lake, IL seeks an experienced leader to oversee the QC Microbiology Laboratory, supervising environmental monitoring, bioburden, endotoxin, sterility, and water testing while ensuring cGMP and FDA compliance.

You will lead investigations, support inspections, and ensure readiness for audits. The role requires guiding lab operations, training staff, and driving CAPAs using Quality Risk Management.

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 environment with environmental monitoring, sterility testing, and microbiological investigations.
• Minimum 2 years of supervisory or technical leadership experience preferred.

Responsibilities

• Provide microbiological oversight for aseptic manufacturing operations, including environmental monitoring programs.
• Collaborate with supervisors and management to align goals and elevate risks.
• Train, coach, and develop laboratory personnel; manage performance evaluations and counseling.

Skills

Supervisory leadership

Data trending

Effective communication

LIMS experience

Microbiology risk assessments

Education

Bachelor's degree in Microbiology or related life science

Tools

LIMS

Electronic QA systems

Job description

Baxter International Inc. in Round Lake, IL seeks an experienced leader to oversee the QC Microbiology Laboratory, supervising environmental monitoring, bioburden, endotoxin, sterility, and water testing while ensuring cGMP and FDA compliance.

You will lead investigations, support inspections, and ensure readiness for audits. The role requires guiding lab operations, training staff, and driving CAPAs using Quality Risk Management.