Quality Control Microbiologist

Harba Solutions Inc.; Cincinnati (OH); On-site; USD 65,000 - 85,000; Full time

Job summary

Harba Solutions Inc. seeks a skilled microbiology QC professional to support aseptic and sterile manufacturing environments.

You will perform environmental monitoring, utility sampling, and critical microbiological tests while ensuring strict gowning and cleanroom protocols. The role involves writing GMP documentation, SOP reviews, and contributing to deviations and root cause analyses within a QC team supporting both OSD and sterile processes.

Qualifications

• Bachelor's or Master's degree in Microbiology, Biology, or related field is required.
• Minimum of three (3) years of microbiology experience in pharma/biotech/medical device environments.
• Proficiency with microbiological testing methods and lab equipment (endotoxin, bioburden, conductivity).
• Experience training or mentoring others in a QC environment.
• Exposure to TLC or broader analytical microbiology techniques.
• Experience in cleanroom environments and aseptic techniques.
• Familiarity with EtO and gamma irradiation sterilization processes is preferred.

Responsibilities

• Perform environmental monitoring in aseptic and sterile manufacturing areas.
• Conduct utility sampling and testing (water and compressed gas systems).
• Perform microbiological testing (bioburden, endotoxin, conductivity).
• Work in Grade A/B aseptic environments with proper gowning procedures.
• Execute routine floor sampling and lab-based testing activities.
• Write, review, and revise SOPs, GMP documentation, and technical reports.
• Support and lead deviation investigations and root cause analysis.
• Maintain chain of custody and sample tracking documentation.
• Participate in risk assessments and quality investigations.
• Collaborate with a QC team supporting OSD and sterile manufacturing.

Skills

Microbiology

Training/Mentoring

Aseptic technique

Documentation

Education

Bachelor's or Master's in Microbiology/Biology

Tools

Endotoxin testing equipment

Bioburden testing equipment

Conductivity testing equipment

Job description

• Perform environmental monitoring in aseptic and sterile manufacturing areas
• Conduct utility sampling and testing, including water and compressed gas systems
• Perform microbiological testing such as bioburden, endotoxin, and conductivity testing
• Work in Grade A/B aseptic environments with proper gowning procedures
• Execute routine floor sampling and laboratory-based testing activities
• Write, review, and revise SOPs, GMP documentation, and technical reports
• Support and lead deviation investigations and root cause analysis
• Maintain chain of custody and sample tracking documentation
• Participate in risk assessments and quality investigations
• Collaborate with a QC team supporting both OSD and sterile manufacturing

Qualifications:

• Bachelor's or Master's degree in Microbiology, Biology, or a related scientific discipline.
• Minimum of three (3) years of relevant microbiology experience in a pharmaceutical, biotech, or medical device environment.
• Proficiency with microbiological testing methods and laboratory equipment such as endotoxin, bioburden and conductivity testing.
• Experience training or mentoring others in a QC environment
• Exposure to TLC or broader analytical microbiology techniques
• Experience working in cleanroom environments and applying aseptic techniques.
• Familiarity with sterilization processes such as ethylene oxide (EtO) and gamma irradiation is preferred.