Diagnostic Laboratory Technician
Brief Summary of cGMP Compliance related to Job Description:
The Diagnostics Laboratory Technician will conduct testing on samples submitted by biopharmaceutical manufacturers and research facilities. Training and duties will include performance of all procedures and operations directly relating to mycoplasma protocols in compliance with CGMP standards. These include aseptic technique, direct culture procedures, subculture procedures, microscopy, media preparation, record keeping, and laboratory maintenance activities. This position will require weekend work on a rotating basis with colleagues.
Description of duties and responsibilities:
Primary Duties: This position involves the performance of all procedures and operations directly relating to the Diagnostics Testing Laboratory.
• Prepare and inoculate (using aseptic techniques) of test samples and control organisms into broth, agar, and cell cultures following established mycoplasma testing protocols.
• Subculture of broth cultures onto agar plates.
• Monitor ongoing agar and broth cultures.
• Perform DNA fluorochrome related activities including preparation, fixation, staining, and diagnostic interpretation (fluorescent microscopy) of sample and control slides.
• Perform routine monitoring, maintenance, and cleaning of mycoplasma testing related instruments and equipment as per established schedules.
• Prepare and maintain required frozen stock mycoplasma control organisms, and record keeping activities for all above functions.
• Adhere to CGMP regulations as they apply to these duties will be essential to this position.
• Support Quality Control and Quality Assurance on the performance improvement experiments.
• Accurately perform technical reviews of SOP’s, client reports and other related documents
• Perform other duties as assigned
• Qualified candidate will possess a B.S. Degree in Biology, a related field or an equivalent combination of education, training and experience.
• 3 to 5 years of relevant and recent laboratory experience or experience in a regulated environment is preferred.
• Knowledge of and experience with aseptic technique is highly desirable.
• Team oriented individual with excellent communication skills as well as the ability to pay critical attention to detail are required.
• Candidate should be well organized and be able to independently execute laboratory work flows.
• Enthusiasm for learning and contributing to improved patient outcomes.