Job Summary: Quality Control Microbiology Technician 1 will provide clean room support for batch production and ensuring procedure adherence during filling of product. Utilize appropriate controlled documents and assist in quality control deviations/investigations. Responsibilities: • Ensure clean rooms and associated areas meet the required cleanliness standards as per company procedures. • Adhere to strict gowning and personal hygiene practices to prevent contamination and maintain integrity of the clean room environment. • Perform gowning qualification training for individuals from all departments who must enter ISO 7 classified areas. • Monitor and maintain clean room equipment such as viable and non-viable samplers to ensure optimal performance and compliance with established standards. • Perform and lead routine environmental monitoring activity in ISO 7 Classified Areas • Work with production to resolve Quality issues and ensure documentation is complete. • Perform routine and non-routine viable, non-viable and surface environmental monitoring in all classified areas of the facility. • Incubation and enumeration of samples related to environmental monitoring processes. • Train new personnel on enumeration activities • Evaluate organisms by colony morphology and perform subculturing. • Train new personnel on colony morphology assessment and subculturing activities. • Continuous improvement activities for environmental monitoring program. • Provide quality control and microbiology support for operations. • Collect, submit and manage microbiological samples to third party testing laboratories. • Generate data reports and/or other compliant documentation from internal EM results or external testing results. • Maintain timely assembly, reporting, and review of all routine and production environmental monitoring results and release testing results generated. • Assist with QC Microbiologists (and other investigators) with investigations as they relate to environmental monitoring or other quality control deviations. • Assist QC Microbiologists with data trending and data reporting as they relate to environmental monitoring or other data-generating processes. • Perform routine testing or cleaning associated with the BioSafety Cabinet. • Lead and train new personnel on the cleaning procedures and testing procedures carried out in the BioSafety Cabinet • Assist in process, procedural, equipment issues via experimentation or revision of procedures. • Other duties as assigned. Required Skills/Abilities: (examples) • Experience with cGMP aseptic manufacturing environment. • Strong attention to detail. • Comfortable in a fast-paced, small company environment and able to adjust workload based upon changing priorities. • Preferred previous pharmaceutical experience. • Proficient in using Microsoft Word, Excel, PowerPoint, Outlook. • Familiarity with 21 CFR Part 11/210/211 Education and Experience: • Associate or Bachelor’s degree in Microbiology, Biology, or related life sciences. • Experience in microbiology or quality control preferred. • Experience in a cGMP or cleanroom setting preferred. Physical Requirements: • Prolonged periods of sitting at a desk or laboratory bench and working on a computer. • Must be able to lift up to 50 pounds at times. The application window for this position is anticipated to be open at least 25 days