Quality Laboratory Technician

Job Title

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 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

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.