Quality Control Microbiologist

Harba Solutions Inc.; Cincinnati (OH); On-site; USD 65,000 - 95,000; Full time

Job summary

Harba Solutions Inc. in Cincinnati seeks an experienced microbiologist to perform environmental monitoring in aseptic manufacturing areas and to conduct utility sampling and testing of water and gas systems.

You will perform microbiological testing (bioburden, endotoxin, conductivity) in Grade A/B environments, write GMP documents, and support deviation investigations with root cause analysis and risk assessments.

Qualifications

• Bachelor’s or Master’s degree in Microbiology, Biology, or a related scientific discipline.
• Minimum of three years of microbiology experience in pharma/biotech/medical device.
• Experience with endotoxin, bioburden and conductivity testing; laboratory equipment.

Responsibilities

• Perform environmental monitoring in aseptic and sterile manufacturing areas.
• Conduct utility sampling and testing, including water and gas systems.
• Perform microbiological testing such as bioburden, endotoxin, and conductivity testing.
• Work in Grade A/B aseptic environments with proper gowning procedures.
• 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.

Skills

SOP writing

Deviation investigations

Root cause analysis

Laboratory testing

Quality investigations

Mentoring

Team collaboration

Aseptic technique

Education

Bachelor’s or Master’s degree in Microbiology

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.