Quality Control Microbiologist

We are looking for a motivated Microbiologist to join our Quality Control team. This position will perform microbiological testing of raw materials, products, water, and production areas while ensuring compliance with cGMP, SOPs, USP methods, and FDA requirements. The ideal candidate will help maintain a safe, high-quality, and contamination-free production environment. Minimum Required Qualifications Bachelor’s degree (BA or BS) in Microbiology, Biology, Biomedical Science, or a closely related science required; master’s degree in microbiology or a related science is preferred. Minimum of 1–2 years of microbiology laboratory experience in a cGMP-regulated pharmaceutical, nutraceutical, food, or dietary supplement manufacturing environment. Strong hands-on knowledge of microbiological techniques, including plating, media preparation, organism identification, environmental monitoring, personnel monitoring, and water testing. Familiarity with cGMP, FDA regulations, and USP standards applicable to microbiological laboratory operations and dietary supplement manufacturing. Ability to interpret microbiological assay data, follow written procedures precisely, and maintain accurate and complete laboratory records in compliance with data integrity requirements. Strong attention to detail, organizational skills, cross-functional communication skills, and ability to assist in resolving microbiological and quality-related technical issues; bilingual proficiency in English and Spanish is preferred. Essential Functions Understand and follow all procedures and processes required for work always performed under cGMP regulatory compliance. Perform all assigned microbiological testing of raw materials, in-process materials, finished products, and process water in accordance with approved SOPs, USP methods, and cGMP requirements. Conduct environmental and personnel monitoring activities in manufacturing and packaging areas; perform required testing and document results in accordance with the environmental monitoring program. Prepare and sterilize microbiological media, reagents, and laboratory supplies; ensure all materials are properly prepared, labeled, and stored. Maintain and monitor microbial cultures and reference organisms in the microbiology laboratory; ensure all cultures are properly maintained, documented, and handled in accordance with applicable SOPs. Inspect manufacturing equipment and production personnel for potential sources of microbial contamination; document findings and escalat e any concerns to the QC Supervisor immediately. Review microbiological assay data; evaluate the acceptability of results against established specifications and acceptance criteria; escalat e any OOS, out-of-trend, or anomalous results promptly. Document microbiological test data, results, and observations clearly, accurately, and completely in laboratory notebooks, logbooks, worksheets, and electronic systems in compliance with cGMP data integrity requirements. Support microbiological OOS investigations and root cause analyses by providing accurate data, technical assessments, and complete supporting documentation. Work cross-functionally with QA, Manufacturing, Packaging, and Purchasing teams to identify and assist in resolving microbiological and quality-related technical issues. Maintain the microbiology laboratory in a clean, organized, safe, and fully compliant biosafety condition; participate in proficiency testing, training activities, continuous improvement initiatives, and perform all other duties as assigned by the QC Supervisor or QC Manager. #J-18808-Ljbffr Nutrition Formulators