Agenus

  • QC Analyst, Microbiology

    Job Locations US-MA-Lexington
    Job ID
    2018-1384
    Category
    Quality
  • Overview

    Conducts routine and non-routine microbiological testing of raw materials, stability samples and in-process and finished formulations according to standard operating procedures.  Performs organism identification and reads and interprets microbiological cultures and other related tests which may include but not be limited to environmental monitoring, sterility tests, growth promotion, microbial limits test and antimicrobial effectiveness tests.  Performs environmental monitoring and processes the data to   compile environmental monitoring status reports.  Calibrates and maintains laboratory equipment.  Participates in the preparation of investigations, summaries and reports.  Reviews data obtained for compliance to specifications and reports abnormalities.  Revises and updates standard operating procedures as needed. 

    Responsibilities

    • Microbiological testing of in-process, development, stability, raw materials and final product samples.
    • Performance of testing in accordance with cGMP and standard operation procedures.
    • Environmental monitoring including air viable, surface viable and total particulate during routine monitoring and dynamic fill/finish procedures.
    • Water monitoring including collection and Endotoxin, Total Organic Carbon, Bioburden and Conductivity analysis.
    • Final buffer release testing including Osmolality, Conductivity, Endotoxin and pH.
    • Sterility testing using direct inoculation and membrane filtration methods and Endotoxin testing by chromogenic end-point test method for in-process, stability and final product samples.
    • Revision and development of standard operating procedure as needed.
    • General laboratory support, including but not limited to sample receipt, inventory control, reagent preparation and equipment, instrument maintenance and media growth promotion testing.
    • Environmental data entry and trend analysis.
    • Monitoring of temperature controlled units using REES monitoring system.
    • Peer training and data review

    Qualifications

    • Requires B.S. in a scientific discipline or equivalent
    • Minimum 0-3 years relevant experience in a GMP environment
    • Prior knowledge of aseptic processing, media fills, biopharmaceutical manufacturing and clean room environment preferred.
    • Strong oral and written communication

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