Job Description
Job Title: Microbiology Laboratory Technician – Quality Control Job Description This role performs and reviews microbiological analysis of in-process, release, and stability samples for active pharmaceutical ingredients and filled products in a cGMP-regulated quality control laboratory. You will prepare and test microbiological samples, support water testing and preventive maintenance programs, and ensure all work meets regulatory, site, and corporate standards. The position offers hands-on training in bioburden testing and additional microbiological methods, with clear opportunities for professional growth and development within a leading pharmaceutical environment. Responsibilities Perform and review microbiological analysis of in-process, release, and stability samples of APIs and filled products in accordance with cGMP, site, and corporate procedures. Prepare microbiological media accurately and consistently to support routine and specialized testing. Wash and sterilize laboratory equipment and media using autoclaves, ensuring proper sterilization cycles and documentation. Conduct bioburden testing of utilities and product samples via membrane filtration, surface spreading, and pour plate methods. Read and interpret environmental monitoring samples and microbiological media, including colony morphology and counts, to assess environmental and product quality. Ensure the accuracy and scientific soundness of laboratory data by following established methods, documenting results clearly, and reviewing data for completeness and correctness. Maintain GMP compliance within the laboratory, including adherence to SOPs, data integrity requirements, and proper documentation practices. Maintain testing proficiency for assigned methods by following structured testing plans, completing required training, and participating in ongoing competency assessments. Deliver timely laboratory results and support investigations by meeting testing timelines, prioritizing work, and communicating delays or issues promptly. Provide operational support to the QC laboratory, including equipment use, routine maintenance support, and coordination with other team members. Support the site water testing program by performing and documenting microbiological testing of water systems in line with established protocols. Support the laboratory preventive maintenance program by coordinating or assisting with scheduled maintenance and ensuring equipment is ready for use. Follow safety procedures when working around odorous or hazardous materials and when working at elevated heights or on ladders. Perform other related laboratory duties and accountabilities as assigned to support overall QC and site objectives. Essential Skills Associate's degree in a scientific field or an equivalent combination of education and relevant experience (preferred). Minimum of one (1) year of experience in a clinical, industrial, or pharmaceutical laboratory (a plus). Hands-on experience with preparation of microbiological media. Experience washing and sterilizing laboratory equipment and media using autoclaves. Experience reading and interpreting environmental monitoring samples and microbiological media. Experience performing bioburden testing of utilities and product samples via membrane filtration, surface spreading, and pour plate methods. Ability to perform routine microbiological testing in accordance with SOPs and GMP standards (a plus). Knowledge of basic laboratory techniques and good laboratory practices (a plus). Familiarity with cGMP requirements and quality control principles in a pharmaceutical or similar regulated environment. Strong attention to detail and ability to produce accurate, scientifically sound data (preferred). Effective verbal and written communication skills to document results and interact with cross-functional teams (a plus). Ability to execute testing according to a structured plan and manage workload to meet timelines (a plus). Physical ability to move equipment and supplies weighing up to 33 pounds within the facility. Ability to perform close precision work with hands for tasks such as plating, filtration, and pipetting. Ability to remain in a stationary position (sitting or standing) for approximately 50% of the time. Corrected vision to 20/25 and color vision sufficient for reading media and interpreting test results. Ability to occasionally ascend and descend ladders and work at elevated heights. Ability to occasionally work around odorous and/or hazardous materials while following safety procedures. Additional Skills & Qua