The Aseptic Quality Operations group supports the onsite small scale commercial manufacturing facility. The QC Microbiology Laboratory Technician conducts routine sampling and testing of cleanrooms environments, water, air and pure steam systems. The QC Microbiology Laboratory technician performs field and lab analysis of environmental and utility samples and identification of microorganisms according to defined procedures.
Duties/Responsibilities: (describe the most critical responsibilities/accountabilities of this position)
• Perform laboratory analysis of samples, using aseptic technique, following established procedures and in full compliance with official compendia, health authority regulations, and established Client policies.
• Conduct qualification of methods and/or other laboratory studies, according to scientific protocols.
• Maintains accurate records of work performed and documents results, according to good documentation practices and established procedures as well as perform data entry into LIMS.
• Assist with review of worksheets, as assigned.
• Assists in the investigation of OOS results in areas of assigned responsibility.
• Operates and maintains instruments, while ensuring the reliability of instrumentation through proper maintenance, with ability to troubleshoot minor issues.
• Must analyze, evaluate, and interpret data, notifying clients of results, and assisting to resolve issues, if applicable. Identify opportunities for workflow and procedural improvements.
• Promotes quality, safety and health, by ensuring clean work area, and adherence to procedures and safety culture.
• Must participate in continuous improvement using lean principles to assist with streamlining and making the laboratory efficient.
• Work schedule includes weekends and holidays.
Knowledge of aseptic technique, environmental monitoring, and microbiological Quality Control testing and procedures preferred. Has excellent manual dexterity and aseptic technique.
Has ability to complete sampling or testing assignments in a timely and compliant manner, with minimal supervision.
Perform limited interpretation of data. Demonstrate ability to handle multiple assignments simultaneously and complete assignments in a timely and compliant manner, with minimal supervision.
Knowledge of cGMPs and compendia testing preferred. Must have effective verbal and written communication skills.
B.S. degree in Biological Sciences or related field with 0-3 years of QC microbiology laboratory experience preferred