QC Microbiologist II – Aseptic Cleanroom Specialist

Medium; Nashville (TN); On-site; USD 65,000 - 90,000; Full time

Job summary

August Bioservices in Nashville, TN is seeking a QC Microbiologist II to support the microbiological control program in a sterile injectable manufacturing facility. The role includes environmental and utility monitoring, microbiological testing of materials and products, data review, and regulatory compliance under cGMP.

You will perform environmental monitoring in ISO Class 5–8 cleanrooms, conduct tests such as bioburden and endotoxin, review results, and contribute to investigations and

Qualifications

• Bachelor’s degree in Microbiology or related life science required.
• 2–4 years of QC Microbiology experience in sterile injectables or aseptic manufacturing.
• Hands-on environmental monitoring of cleanrooms and isolators; aseptic technique.
• Knowledge of USP methods and FDA/EMA/ICh Q7/Q9/Q10 guidance.
• Proficiency in Microsoft Office.

Responsibilities

• Perform environmental monitoring in ISO Class 5–8 cleanrooms.
• Conduct microbiological assays including bioburden and endotoxin testing.
• Review data and ensure traceability per ALCOA+ and cGMP.
• Support deviations, investigations, and change controls as needed.
• Assist with equipment qualifications and method transfers.

Skills

Attention to detail

Data integrity

Effective communication

Independent cross-functionalCollab

Education

Bachelor's degree in Microbiology or related life science

Tools

MS Office

Job description

August Bioservices in Nashville, TN is seeking a QC Microbiologist II to support the microbiological control program in a sterile injectable manufacturing facility. The role includes environmental and utility monitoring, microbiological testing of materials and products, data review, and regulatory compliance under cGMP.

You will perform environmental monitoring in ISO Class 5–8 cleanrooms, conduct tests such as bioburden and endotoxin, review results, and contribute to investigations and