San Diego, CA, US
11h ago

Primary Responsibilities

for Role

  • Follows all safety rules
  • Maintains accurate and complete training records
  • Understands and executes written procedures in accordance with cGMP
  • Operates basic filling equipment
  • Maintains detailed and accurate device history records
  • Completes and forwards devise history records for review in a timely manner
  • Operates pipetman
  • Stocks manufacturing area with supplies
  • Cleans manufacturing areas, to include lab ware, storage totes, equipment, shelves benches and sinks and removes trash
  • Operates Luminometer
  • Additional Responsibilities

  • Assists with material handling and staging of materials for process orders.
  • Receives and verifies the accuracy of materials transferred from the Warehouse; may perform material and labor transactions in the ERP System;
  • may be responsible for flushing water ports and eyewash stations; applies labels according to SOP’s and performs refrigerator / freezer maintenance.

  • Responsible for maintaining laboratory environment in one functional area (multiple filling and / or bulking stations).
  • Maintain laboratory and laboratory stock.
  • Perform general lab audits to ensure compliance with current GMPs and regulations.
  • Perform equipment maintenance.
  • Open and close work orders; ensure ERP transactions are performed in a timely and accurate manner to ensure inventory accuracy.
  • Assist in the preparation of device master records & SOPs.
  • Train new lab personnel.
  • Formulation of subassembly solutions and small reagent bulks.
  • Responsible for decontamination, transportation, handling, and disposal of chemicals and biological waste (human serum).
  • Performs operation / calibration of all general lab equipment.
  • Knowledge, Skills and Abilities

  • General understanding of recordkeeping and mathematics. Working knowledge of laboratory science, procedures, techniques, instruments & equipment.
  • Working knowledge of general laboratory safety and record keeping. Knowledge of current GMP’s.

  • Blood Borne Pathogen training
  • Basic computer knowledge
  • Education

    Typically requires High School or AA


    Typically 2-4 years of related experience or for AA 0-2 years of related experience

    Occupational Demands

    May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and / or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.

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