QC Microbiologist III – Cleanroom & Aseptic Lab

August Bioservices; Nashville (TN); On-site; USD 55,000 - 75,000; Full time

Job summary

August Bioservices in Nashville, TN, seeks a QC Microbiologist II to support the microbiological control program in a sterile injectable manufacturing facility. You will perform environmental monitoring, testing of materials, and data review to ensure cGMP compliance and product sterility.

Ideal candidates hold a B.S. in Microbiology or related field with 2–4 years of QC Microbiology experience, strong data integrity, and proficient collaboration across teams in a fast-paced CDMO environment.

Qualifications

• Bachelor’s degree in Microbiology or related life science.
• 2–4 years of QC Microbiology experience for sterile injectables or aseptically manufactured products.
• Hands-on environmental monitoring of cleanrooms and isolators; aseptic technique.
• Knowledge of USP methods and regulatory guidance (FDA/EMA/ICH).
• Proficiency in Microsoft Office and attention to data integrity.
• Strong communication and teamwork abilities.

Responsibilities

• Perform viable and non-viable environmental monitoring in ISO Class 5–8 cleanrooms.
• Conduct personnel monitoring to assess aseptic technique.
• Collect and test environmental and utility samples per approved plans.
• Trend data and support sterility assurance activities.
• Execute microbiological assays (bioburden, endotoxin, growth promotion).
• Support media fills and aseptic process simulations.
• Test raw materials, in-process, and finished products per methods.
• Maintain microbial culture stocks and reference organisms.
• Document work per cGMP and ALCOA+ principles.
• Review data, SOPs, and qualification protocols; prepare reports.
• Participate in audits and drive process improvements.

Skills

Environmental monitoring

Aseptic technique

Data integrity

Microsoft Office

Communication skills

Education

Bachelor’s degree in Microbiology or related life science

Tools

Compendial methods (USP)

cGMP knowledge

Job description

August Bioservices in Nashville, TN, seeks a QC Microbiologist II to support the microbiological control program in a sterile injectable manufacturing facility. You will perform environmental monitoring, testing of materials, and data review to ensure cGMP compliance and product sterility.

Ideal candidates hold a B.S. in Microbiology or related field with 2–4 years of QC Microbiology experience, strong data integrity, and proficient collaboration across teams in a fast-paced CDMO environment.