REPRESENTATIVE RESPONSIBILITIES Facility and Equipment: - Oversee and perform day-to-day operations including cleanroom facilities maintenance, project management, and fee-for-service support as assigned. Troubleshoot and correct erroneous results or problems with laboratory equipment. Maintain, repair, calibrate, and/or validate equipment as needed. Monitor proper equipment use by all personnel. Maintain inventory of laboratory supplies and equipment; order supplies from vendors and storeroom and ensure proper storage requirements are met. Maintain stocks of chemicals and solutions. Report equipment and/or facility related system failures or alarms to laboratory management or QA team. Operations - Perform day-to-day operations including cleanroom facilities maintenance and equipment maintenance plus fee-for-service support as assigned. Operate standard laboratory equipment according to protocol. Promptly respond to and troubleshoot erroneous results or problems with laboratory equipment or facilities. Order supplies from vendors and storeroom and ensure proper storage requirements are met. Maintain stocks of chemicals and solutions. Report facility and equipment failure and alarms to laboratory management or QA team. Perform maintenance and cleaning of the cleanroom manufacturing facility. Routinely perform the Environmental Monitoring sampling and/or testing of the sampled media. Support equipment and facility calibration and validation activities. Request and schedule services with vendors related to lab, cleanroom, and equipment operations. Complete accurate and detailed records. Complete and maintain training required to perform assigned tasks. Compliance - Perform work with a high level of integrity and honesty. Practice a high level of integrity in maintaining confidentiality. Maintain required documentation systems. Provide Material Safety Data Sheet (MSDS) training according to regulations. Communicate with external vendors to obtain technical information as needed. Assists in daily operations of the laboratory including answering phone, maintaining lab supplies, organization, and cleanliness. Provide written and oral reports to management on a regular basis. Provide appropriate safety monitoring checks as assigned (radiation safety, biosafety, etc.) Perform other duties as assigned. Process Improvement - Create, modify, and follow Standard Operating Procedures (SOPs) and Validation Protocols. Cooperate with performance improvement initiatives and other compliance activities. Interact with QA to coordinate manufacturing, processing, and testing activities (i.e. production suite cleaning schedule, release of the production suite, issuance of batch record, completion of equipment validations, etc.). Cooperate with Quality Assurance group to ensure the quality of product, test results and compliance. Perform assigned duties strictly according to SOP. Maintain optimal protocol and assay accuracy by conducting regular quality and reproducibility checks. Maintain required proficiency and competency requirements. Manufacturing - Analyze data, perform statistical and graphical analysis of data, and interpret results. Perform qualification and validation activities for equipment/instrumentation, facilities, laboratory methodology and quality assurance procedures that are essential to the GxP operations.. Maintain an active role in the department meetings, presentations, and publications. Training & Development - Train laboratory personnel on proper GxP and regulatory compliance techniques. Act as a mentor to more junior staff. Serve as the contact for resolution of complex issues, provide education, guidance and work direction. May provide input and feedback to managers on hiring decisions, professional development and performance management. Development, technology transfer, scale up, manufacturing/processing/ and or testing; Qualifications and validations. Analyze data and assist others.