Lab Tech

Job Responsibilities:

The Senior Lab Operations and Systems Support Specialist is responsible for ensuring the efficient operation of analytical laboratories at the Irvine campus. This role involves oversight of laboratory systems, compliance with regulatory requirements, and coordination of lab support activities, without direct involvement in calibration or bench chemistry. Key responsibilities include:

Lab Operations & Systems Support

• Serve as the Business System Owner for key laboratory computer systems, including the Electronic Lab Notebook (ELN), Laboratory Information Management System (LIMS), and Local Admin Systems.
• Oversee general laboratory operations in a GxP-compliant environment, adhering primarily to GMP regulations.
• Conduct routine laboratory walkthroughs to identify alarms and ensure proper functioning of equipment and environmental conditions.
• Monitor and log temperature trends; respond to temperature alarm notifications and initiate service requests when necessary.
• Assist with onboarding of new equipment, including proper setup, qualification activities, and execution of change control processes.
• Coordinate and assist with movement of laboratory equipment, including initiating service requests, obtaining necessary approvals, and ensuring proper documentation.

• Ensure all activities are compliant with applicable regulatory requirements and internal SOPs.
• Assist with computer system validation and prepare compliance-related documentation.
• Investigate out-of-tolerance (OOT) incidents using the Asset Management System and contribute to root cause analysis and corrective actions.
• Review calibration and maintenance reports provided by vendors and internal calibration technicians.
• Maintain accurate and timely documentation for all lab support activities, in line with GMP documentation standards.
• Complete annual GMP training and uphold strict documentation practices.

• Escort external vendors for equipment calibration and maintenance activities.
• Schedule and execute service requests for new equipment setup and asset management system updates.
• Support the coordination and execution of qualification and validation activities for new lab instruments.

• Monitor stability chambers, ensuring environmental compliance through visual inspections and temperature trend monitoring.
• Coordinate stability chamber maintenance and cleaning schedules.
• Manage stability inventory, including the receipt, storage, distribution, and disposal of stability study samples.
• Ensure timely and accurate logging of critical sample receipt and tracking within LIMS.
• Schedule and execute sample distribution from stability chambers to designated analytical labs.

• Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents.
• Experienced in GMP regulated drug development environment.
• Must possess a BS in molecular biology, biochemistry, or related field with at least three years of relevant experience.