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Senior Reagent Production Specialist

2 months ago

Redwood City California, United States Guardant Health Full time
Job Overview


The Senior Reagent Production Specialist plays a crucial role in the Clinical Laboratory by overseeing the reception, labeling, documentation, and aliquoting of reagents. This position also entails the qualification of incoming reagents to ensure they meet the necessary standards.


In addition to these primary responsibilities, the Senior Reagent Production Specialist will assist in the preparation and labeling of reagents for automated instruments.


This role requires providing backup support to Clinical Laboratory and Reagent Production teams as needed.


Key Responsibilities:

  • Manage the schedule for reagent production activities.
  • Prepare and aliquot reagents essential for the Guardant360 test, pharmaceutical projects, and external clients.
  • Manufacture controls, reagents, and kits necessary for various laboratory tests.
  • Ensure all incoming reagents are processed and documented accurately.
  • Assist in maintaining adequate inventory levels of reagents used in the Clinical Operations laboratory.
  • Coordinate reagent qualification activities with Clinical Operations staff as required.
  • Review and complete reagent qualification records.
  • Assist with reagent stability activities.
  • Perform miscellaneous laboratory duties as assigned and provide assistance to colleagues as needed.
  • Contribute to the development and updating of Standard Operating Procedures (SOPs) related to reagent preparation and qualification.
  • Communicate effectively and professionally with both internal and external stakeholders.
  • Conduct molecular testing using various techniques, including next-generation sequencing.
  • Engage in Quality Control/Quality Assurance activities as part of the commitment to patient safety.
  • Participate in essential laboratory functions such as reagent qualification, inventory management, procedure writing, inspection preparation, assay validation, and investigation.
  • Adapt work schedule as necessary to meet operational demands.
  • Perform laboratory tests and procedures according to established standard operating procedures.
  • Identify and troubleshoot issues affecting test performance independently.
  • Document all quality control procedures and corrective actions taken when deviations occur.
  • Conduct routine preventive maintenance and training for new laboratory personnel.
  • Maintain an adequate supply of laboratory materials for daily operations.
  • Conduct annual reviews of Standard Operating Procedures.
  • Report any concerns regarding test quality or safety to the Laboratory Supervisor.
  • Participate in the introduction of assay improvements and new configurations.
  • Perform additional laboratory duties as assigned.