Quality Laboratory Technician

Responsibilities: • Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. • Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times. • Follow directions properly, work cooperatively as an individual contributor and as a team member. • Ability to multi-task and work flexible work schedule. • Intermediate written and verbal communication skills. • Ability to interpret and write general business documents and technical documents. • Ability to follow direction well, work cooperatively as an individual contributor and as a team member. • Ability to gown and maintain a sterile work environment. • Ability to work independently for extended periods of time. • Perform Environmental Monitoring on routine basis. • Collect viable and non-viable samples within controlled environments. • Collect viable and non-viable samples for compressed gases. • Collect personnel glove and gown samples. • Participate in aseptic process qualifications, such as aseptic gowning and media reads. • Perform microbial isolation techniques and perform Gram stain identifications. • Evaluate environmental/personnel monitoring samples and create NOEs for action levels. • Send out samples to contract labs and track results/reports. • Communicate effectively with QC peers, cross-functional peers and management. • Performs general laboratory cleaning/wipe-down. • Perform routine maintenance of lab equipment. • Under the guidance of management, support special project work. • Document laboratory test results on worksheets, forms and logbooks utilizing Good Documentation Practices. • Enter data in CELabs LIMS System

Education and Experience Required: • Bachelor's degree preferred, preferably in science or related field. • Microbiology lab experience strongly preferred • Minimum 4 years of Environmental Monitoring experience • Understand USP, EP, JP, and FDA microbiology testing requirements • Intermediate level experience with Microsoft Word and Excel. • Experience using LIMS required; CELabs LIMS Systems preferred • Responds to challenges and additional projects in an understanding, positive, and objective manner. • Adaptable to dynamic conditions, work practices, and project timelines. • Ability to multitask, prioritize workload and interpret data accurately. • Able to communicate effectively with functional areas and external agencies. • Fosters teamwork and promotes an environment that motivates others to achieve our goals.