Lead QC Microbiology Lab – Aseptic Manufacturing

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

Benefits offered by this job

ESPP (Employee Stock Purchase Plan)

401(k) Retirement Plan with company匹配

Paid time off 20–35 days

Job summary

Baxter International Inc. is seeking a QC Microbiology Laboratory supervisor to oversee aseptic manufacturing testing, environmental monitoring, and sterility programs. You will lead investigations, support audits, and maintain inspection readiness to ensure compliant operations.

The role requires strong supervisory skills, regulatory knowledge, and experience with FDA/USP guidelines, data integrity, and LIMS, with a focus on quality and CAPA implementation.

Qualifications

• Bachelor's degree in Microbiology, Biology, or related life science.
• 5–7 years of QC Microbiology experience in pharma/biologics/aseptic environments.
• Minimum 2 years of supervisory or technical leadership experience.
• Experience supporting environmental monitoring, sterility testing, and endotoxin testing.

Responsibilities

• Provide microbiological oversight for aseptic manufacturing operations.
• Lead environmental monitoring, bioburden, sterility, and water testing.
• Ensure compliance with cGMP, FDA, USP, and regulatory requirements.
• Lead investigations and CAPA using root cause analysis.
• Prepare and revise SOPs and specifications.
• Support audits and inspection readiness.
• Train and develop laboratory personnel.

Skills

Supervisory skills

Interpersonal skills

Regulatory knowledge

Communication

Data trending

LIMS

Electronic QMS

Bioburden testing

Education

Bachelor's degree in Microbiology

Tools

LIMS

Quality Management Software

Job description

Baxter International Inc. is seeking a QC Microbiology Laboratory supervisor to oversee aseptic manufacturing testing, environmental monitoring, and sterility programs. You will lead investigations, support audits, and maintain inspection readiness to ensure compliant operations.

The role requires strong supervisory skills, regulatory knowledge, and experience with FDA/USP guidelines, data integrity, and LIMS, with a focus on quality and CAPA implementation.