Aseptic QC Microbiologist — Weekend Shift

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

Job summary

August Bioservices in Nashville, TN is seeking a QC Microbiologist to maintain the sterile injectable manufacturing environment. You will perform environmental and utility monitoring, test raw materials, in-process samples, and finished products, and ensure data integrity and regulatory compliance.

The role supports cGMP operations, conducts microbiological assays, and participates in audits and continuous improvement initiatives. Some weekend sampling and off-shift coverage may be required.

Qualifications

• Bachelor’s degree in Microbiology, Biology, Biotechnology, or related life science discipline.
• 1–4 years of experience in QC Microbiology operations for sterile injectables or aseptically manufactured products.
• Hands-on experience with environmental monitoring of cleanrooms and isolators and 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 data integrity.
• Effective communication skills (written, verbal, and presentation).
• Ability to work independently and in cross-functional teams.
• Flexibility to support off-shift or weekend sampling and testing.

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

USP methods

Data integrity

MS Office

Communication skills

Cross-functional teamwork

Flexibility

Education

Bachelor's degree in Microbiology

Tools

Autoclaves

Incubators

Isolators

Particle counters

Job description

August Bioservices in Nashville, TN is seeking a QC Microbiologist to maintain the sterile injectable manufacturing environment. You will perform environmental and utility monitoring, test raw materials, in-process samples, and finished products, and ensure data integrity and regulatory compliance.

The role supports cGMP operations, conducts microbiological assays, and participates in audits and continuous improvement initiatives. Some weekend sampling and off-shift coverage may be required.