Senior QC Microbiologist, Sterile Aseptic GMP

August Bioservices; Nashville (TN); On-site; USD 52,000 - 76,000; Full time

Job summary

August Bioservices, headquartered 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, test materials, review data, and help ensure regulatory compliance and cGMP standards.

You will conduct environmental and utility sampling, microbiological assays, and support method validations, with opportunities to contribute to process improvements and audits.

Qualifications

• Bachelor’s degree in Microbiology, Biology, Biotechnology, or a related life science discipline.
• 2–4 years of experience supporting QC Microbiology operations for sterile injectables or other aseptically manufactured products.
• Hands-on experience with environmental monitoring of cleanrooms and isolators as well as aseptic technique.
• Working knowledge of compendial methods (USP <61>, <62>, <71>, <85>, <1116>) and regulatory guidance (FDA, EMA, ICH Q7/Q9/Q10).
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Strong attention to detail and commitment to data integrity.

Responsibilities

• Perform viable and non-viable environmental monitoring in ISO Class 5–8 cleanrooms, including aseptic filling areas (isolators and RABS).
• Conduct personnel monitoring to assess aseptic technique compliance.
• Collect and test utility samples (WFI, Purified Water, compressed gases) per approved sampling plans.
• Trend and assess environmental and utility data to support cleanroom control and sterility assurance.
• Perform microbiological assays including bioburden, endotoxin, and growth promotion testing.
• Support and handle samples for media fills/aseptic process simulations.
• Test raw materials, in-process, and finished products per USP, EP, and internal methods.
• Maintain and verify microbial culture stocks, control strains, and reference organisms.
• Document all work per cGMP and ALCOA+ principles.
• Review, interpret, and ensure accuracy and traceability of analytical data.
• Author, revise, and review SOPs, test methods, qualification protocols, and reports.
• Summarize data trends and prepare monitoring review reports.
• Provide microbiological input for environmental excursion and deviation investigations.
• Support equipment and laboratory qualifications (e.g., autoclaves, incubators, isolators, particle counters).
• Assist with method validations, verifications, and transfers.
• Maintain a clean, compliant, and organized laboratory.
• Follow biohazard and waste-handling procedures.
• Participate in internal/external audits and provide technical support.
• Identify and support laboratory process improvements and automation initiatives.

Skills

Environmental monitoring

Aseptic technique

Microsoft Office

Attention to detail

Data integrity

Effective communication

Cross-functional collaboration

Independent work

Education

Bachelor's degree in Microbiology/ Biology/ Biotechnology

Tools

Microsoft Office

Job description

August Bioservices, headquartered 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, test materials, review data, and help ensure regulatory compliance and cGMP standards.

You will conduct environmental and utility sampling, microbiological assays, and support method validations, with opportunities to contribute to process improvements and audits.