QC Microbiologist II — Aseptic Sterile Fill & Environment

August Bioservices LLC; Nashville (TN); On-site; USD 60,000 - 80,000; Full time

Job summary

August Bioservices LLC in Nashville, TN is seeking a QC Microbiologist II to support the microbiological control program in a sterile injectable manufacturing facility. The role involves environmental and utility monitoring, testing raw materials, in‑process samples, and finished drug products, with data review and investigations to ensure regulatory compliance and cGMP standards.

Responsibilities include environmental monitoring in ISO 5–8 cleanrooms, aseptic technique assessment, collecting

Qualifications

• Bachelor’s degree in Microbiology or related life science
• 2–4 years of QC Microbiology experience in sterile injectables or aseptically manufactured products
• Hands-on experience with environmental monitoring of cleanrooms and isolators and aseptic technique
• Working knowledge of USP methods and regulatory guidance (FDA/EMA/ICH)
• Proficiency in Microsoft Office
• Strong attention to detail and data integrity
• Effective written and verbal communication
• Ability to work independently and in cross-functional teams
• Flexibility to support off-shift/weekend sampling as needed
• Ability to lift up to 25 lbs and work in gowning/controlled environments

Responsibilities

• Perform viable and non‑viable environmental monitoring in ISO Class 5–8 cleanrooms and aseptic areas
• Conduct personnel monitoring to assess aseptic technique compliance
• Collect and test utility samples (WFI, Purified Water, compressed gases) per approved plans
• Trend and interpret environmental and utility data to support cleanroom control and sterility
• Perform microbiological assays including bioburden, endotoxin, and growth promotion testing
• Support 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 (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

Data integrity

Attention to detail

Regulatory knowledge

Communication skills

Team collaboration

Education

Bachelor’s degree in Microbiology

Tools

Autoclaves

Incubators

Isolators

Particle counters

Job description

August Bioservices LLC in Nashville, TN is seeking a QC Microbiologist II to support the microbiological control program in a sterile injectable manufacturing facility. The role involves environmental and utility monitoring, testing raw materials, in‑process samples, and finished drug products, with data review and investigations to ensure regulatory compliance and cGMP standards.

Responsibilities include environmental monitoring in ISO 5–8 cleanrooms, aseptic technique assessment, collecting