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Quality Control Microbiologist

1 month ago

Germantown, United States OnconeX Full time

OnconeX is an Immuno-cancer Therapy Company. We are seeking a Quality Control (QC) Microbiologist to support microbiology, environmental monitoring (EM), and utility testing programs for a cGMP facility. The role involves performing routine EM and utility sampling, along with testing in-process materials, finished products, and stability samples.

Key Responsibilities and duties:

  • Perform environmental monitoring and utility testing of the cGMP facility
  • Coordinate and perform microbial isolations and identifications
  • Writes reports and performs investigations for environmental excursions and deviations.
  • Completes data analysis and summary reports for trend reports
  • Perform testing for in-process materials, finished products, and stability samples
  • Performance of maintenance of the laboratories, supplies, and equipment


Qualifications:

  • Bachelor’s Degree in Biology, Microbiology, Biotechnology, Chemistry, Biomedical Engineering or other life science related field
  • Environmental monitoring of controlled environments, personnel and clean utilities.
  • Microbiological testing and analysis on a variety of sample types, related to environmental monitoring, utility, raw materials, and in-process and final product materials.
  • Experience of executing environmental sampling of Classified Areas including active air sampling, surface sampling, and non-viable air sampling
  • Proficient in data entry, review and, approval
  • Provide summaries of test results to appropriate personnel as needed
  • You will be central in all processes associated with environmental monitoring and integral with environmental investigations, excursion report writing
  • Minimum 3 years of relevant post-degree experience in Environmental Monitoring, Aseptic Manufacturing, or Microbiological Laboratory Operations cGMP experience
  • Strong oral and written communication skills
  • Performs other duties as assigned


Ideal candidates will have previous experience in quality control microbiology. Knowledge of aseptic manufacturing environmental monitoring and SOP review, creation, and approval is desirable. Additionally, experience in compliance with cGMP standards, safety and environmental regulations, and data entry proficiency are important for this role.

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