Microbiologist

4 weeks ago

Baltimore, United States PeopleSuite LLC Full time
Scope of Position

Executes the activities of QC Microbiology Laboratory by following approved microbiological and chemical test procedures and ensuring their delivery in an accurate and timely manner following proper safety precautions. Also, provide QC microbiology support to the Aseptic Manufacturing and validation process.

Responsibilities

  • Performs Microbiological Tests and studies by following the established procedures referenced in the official sources
  • Collection of samples (Raw Materials, Excipients, Validation, In-process, and Finished product samples) for microbiological/chemical testing
  • Conducts validations studies and routine tests related to Bioburden tests, Bacterial Endotoxin Tests, Particulate Matter Tests, and Sterility Tests
  • Preparation of microbiological media and diluents by following laboratory procedures
  • Quality Control Testing of microbiological media and reagents
  • Environment Monitoring of Aseptic / Non-aseptic Manufacturing areas and Trending of microbial data obtained from EM/Utilities/Raw Materials/In-process and finished products testing and preparing the periodical summary report.
  • Maintenance of Laboratory inventory
  • Responsible for maintaining the microbiology isolates obtained from EM and Utility Monitoring Program
  • Follow established health and safety procedures and policies related to QC Microbiology Laboratory operations. Perform other related duties as required and assigned by Microbiology Laboratory Management.

Qualifications

  • Must have a thorough understanding of QC Microbiology Laboratory Operations and Sterility Assurance program
  • Sound understanding of cGMP
  • Must have a minimum Bachelor's Degree in Microbiology / Biology or related disciplines
  • Must have 1-2 years of experience as a QC Microbiologist in a Drug/Device manufacturing industry

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