Natera


Position Summary

Executes the preparation and qualification of molecular diagnostic reagents.

Primary Responsibilities

  • Perform routine Quality Control tests on new incoming shipments of raw materials and small-scale manufacturing procedures (formulations and dispensing) reagents following the standard methods and procedures typically under supervision
  • Reviews data obtained for compliance to specifications and reports abnormalities/discrepancies
  • Receive, verify, label, store reagents according to department procedures
  • Coordinate labeling and dispensing for reagents following standard operating procedures with little to no errors
  • Stock laboratory with qualified reagents and consumables as needed
  • Assist with reagent preparation and qualifications
  • Verify that data is properly entered into laboratory inventory system
  • Maintain and update QC Records, QC documentation (raw material specification, reagent qualification, and QC testing), Cleaning and Maintenance Records
  • Document all corrective actions taken when test systems deviate from the established performance specifications as needed
  • Meet expected performance metrics within role as applicable
  • Follows/Ensures GLP (good laboratory practices) and GMP (good manufacturing practices) compliance
  • Reports Non-Conformity of SOPs to lead/supervisor/manager
  • Submit Non-Conformance Report (NCR) when applicable
  • Ensures work is consistently completed in a timely manner
  • Ensures all dispenses are qualified and accounted for
  • Assists in training new hires
  • Assists in training/implementation of new process changes, as needed
  • Recognizes, escalates, and troubleshoot equipment malfunctions and most processing errors according to the laboratory’s standard operating procedures
  • Maintains equipment and instruments in good operating condition (such as calibration and expiration date)
  • Recognizes, documents, and escalates protocol deviations in lab to lead/supervisor/manager
  • Communicates with team and other departments on various platforms (including via e-mail)
  • Provides feedback on day-to-day schedule and tasks to lead/supervisor/manager
  • Assists teammates in completing daily tasks
  • Assists in planning workflow and day-to-day schedule
  • Works intra and inter departmentally to provide support and solutions for workflow.
  • Perform materials, supplies, and equipment tracking and planning in the laboratory for performance of duties
  • Work cross-functionally with other departments to ensure timelines are met
  • Dispose of waste in compliance with Safety & Environmental procedures
  • Able to perform work with minimal supervision
  • Participate in Continuous Improvement Projects
  • Escalates issues/team concerns and suggests possible solutions to lead/supervisor/manager
  • Assist with internal audits and inspection preparation, as needed
  • Provides guidance and constructive feedback to team members
  • Offers suggestions/ideas for improvement and assists with developing team’s troubleshooting and judgement skills
  • Keeps team morale up and maintains professionalism of team members
  • Maintains clean and organized workspace
  • Conducts himself/herself in a professional manner
  • Adheres to Departmental Expectations
  • This role works with PHI on a regular basis both in paper and electronic form and have access to various technologies to access PHI (paper and electronic) in order to perform the job
  • Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire
  • Must maintain a current status on Natera training requirements
  • Employee must pass post offer criminal background check
  • Performs other duties as assigned
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  • Nível de experiência

    Assistente

  • Tipo de trabalho

    Tempo integral

  • Função

    PesquisaAnalistaTecnologia da informação

  • Setores

    SoftwareBiotecnologiaAtendimento médico e hospitalar

São Carlos, SP


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