Job Summary This role involves testing to ensure compliance with Current Good Manufacturing Practices (cGMP) in a manufacturing facility. You will be responsible for evaluating the microbiological quality of products, equipment, process areas, and facility utilities. Responsibilities * Entering laboratory clean-rooms to collect and log samples for microbial analysis. * Performing bioburden and endotoxin sample analysis according to standard operating procedures (SOPs). * Conducting microbial identification analysis. * Carrying out environmental monitoring, including surface, settling, and viable and non-viable particulate air monitoring of aseptic operations and controlled areas. * Verifying the acceptance of commercially prepared microbiological culture media. * Autoclaving microbiological media and laboratory waste as needed. * E nsuring all work is conducted in accordance with regulatory standards, company policies, and SOPs. * Completing test records on time and reviewing data from other analysts for accuracy and completeness. * Assisting in the design and setup of the QC microbiology laboratory and selecting, implementing, and calibrating laboratory instruments. * Participating in microbiological validations for drug substances, in-process controls, buffers, and clean utilities qualification programs. * Providing technical advice to manufacturing personnel in identifying microbiological root causes. * Participating in the transfer of methodologies from other test facilities. * Maintaining laboratory reagents, media, and supplies. * Conducting laboratory investigations and generating reports in response to invalid assays, deviations, OOS/OOT. * Initiating and completing CAPAs and change controls in adherence with site procedures. * Communicating analytical data reports clearly and concisely to management. * Identifying and implementing lab process improvements and lean initiatives. Requirements * You have a proven record of working independently or as part of a team. * You possess strong trouble-shooting and problem-solving skills. * You have strong attention to detail and excellent written and oral communication skills.