Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!
The QC Microbiologist II supports the microbiological control program in a sterile injectable (parenteral) manufacturing facility. This position plays a key role in maintaining the facility’s aseptic control state by performing environmental and utility monitoring, microbiological testing of raw materials, in-process samples, and finished drug products. The role also includes data review, investigation support, and ensuring compliance with regulatory requirements and cGMP standards.
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.
Requirements
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.
Effective communication skills (written, verbal, and presentation).
Demonstrated initiative, accountability, and ability to work both independently and in cross-functional teams.
Flexibility to support off-shift or weekend sampling and testing based on manufacturing needs.
Ability to work in cleanroom gowning and controlled environments for extended periods.
Frequent standing, bending, and walking.
Ability to lift up to 25 lbs and handle routine laboratory equipment and sampling tools.
Shift Hours
Weekend Day shift: Saturday - Monday, 7:00 am - 7:00 pm
At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.
We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!
August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.
