Laboratory Technician

Operate autoclave and standard laboratory equipment (e.g., balance). Support cross-functional teams with appropriate activities. Ensure proper laboratory equipment and functionality, and appropriate levels of laboratory supplies. Initiate/draft LIRs (Laboratory Investigation Records).

• Perform Environmental Monitoring (EM) of aseptic manufacturing operations. 40% facilities. Perform on-the-spot investigations and appropriate follow-up actions under EM excursion situations under direction of senior technicians/management, and per procedure. Environmental Monitoring Requests (EMRs) in a timely manner to release cleanroom to Manufacturing per procedure. Complete personnel monitoring plating of Manufacturing technicians as requested. Sample and test water systems serving manufacturing facility and laboratories. EM includes non-viable and viable air particulate, viable surface sampling, personnel monitoring, and water sampling. Must be able to lift 25 lbs. Wear proper PPE. Follow SOPs to perform Quality Control Laboratory testing. Operate standard laboratory equipment such as balances, autoclaves, CLIMETs, Instron units, and Thermogravimetric analyzer, and air samplers.
• Maintain appropriate databases and spreadsheets to accurately report test results in compliance with current Good Laboratory and Good Documentation Practices. Perform data verification for EM results and data entry. Become a qualified peer reviewer. Ensures that records and raw data are properly recorded, reviewed and retained. Keep supervisor/upper management informed of laboratory operation status. Initiate LIRs in Global Track wise system.
• Execute non-routine test for study protocols and/or equipment re-qualifications. Ensure appropriate levels of laboratory supplies and proper functioning of equipment. Ensure disposal of solutions and media as per SOPs. Monitor preventive maintenance and calibration activities of lab equipment. Sustain 6s and keep laboratory a safe and pleasant working environment.