QC Microbiology

A new academic semester begins. Some students are close to completing their studies and others will begin the job search. It is important you be prepared if you are getting ready to be part of the workforce. Search for information on the roles and responsibilities for different career options.

In this article we focus on understanding the responsibilities for a microbiologist in an industry environment. If you are looking for a microbiology job in the industry, we recommend that you understand what the role of the microbiologist is, what types of tests are performed, why are performed, and how they are executed. In this way you can be better prepared for a job interview.

You may not have the experience performing the testing, but you will be in a better position if you can demonstrate that you know what it is about, you understand the concept, the theory, the technique, and the purpose of the testing.

When we begin to work in the industry, we could say that we start without experience. You cannot execute any procedure until going through the training provided by the company. The previous experiences maybe only help you to speed up the time to complete your training, since you know and understand the concepts, however, you start from the basics.

When you start working in an organization such as a pharmaceutical or medical device manufacturer, you have to go through a training in the microbiological test to be performed and in the standard procedure to execute the method. It is not expected that on your first day you start performing the test immediately.

You have to go through a training, understand the internal procedures of the company, and even observe a certified analyst execute the test several times before you are certified to perform the test.

The process of certifying yourself in a laboratory method requires that you be trained in the internal procedure of the company. Usually you first read and understand the procedure, and then you accompany a certified analyst, whom you observe performing the test. As you observe the execution, you are being trained (“on the job training”). Once you are ready, you will perform the testing with the trainer who will be observing, directing you, clarifying the questions and the execution technique. When you demonstrate proficiency to perform the procedure on your own, you get certified and can execute. The training time depends on your knowledge, the complexity of the method you are doing, and your skills.

In the industry, the microbiology area generally has a quality control function. A representative sample of the batch, product or environmental conditions is taken and subject to a microbiological testing. Based on the test results, conclusions are established related to the quality of the product or process.

Let’s see some of the roles of a microbiologist’s position.

The Microbiology group performs routine microbiology testing on raw materials, components, final product and controlled environments areas. The test methods are already predefined in the policies, internal procedures and the compendial methods like the United States Pharmacopeia (USP). These procedures have to be aligned with FDA regulations and guidelines.

Some examples of tests in which it is convenient to have knowledge or experience include:

  • Water tests (Total Viable count, coliforms, TOC, conductivity)
  • Bioburden tests to product
  • Microbial limit test
  • Sterility test by membrane filtration or direct inoculation. USP <71> establishes basic requirements for the method.
  • Bacterial endotoxin test on water samples, raw material, components and final product. This test can be done using the clot method, kinetic, chromogenic and turbidimetric method
  • Lethality studies
  • Determination of biological indicators (BI) population
  • Qualification of Disinfectants
  • Identification of microorganisms or normal microbial flora
  • Environmental controls. This topic includes routine environmental monitoring of controlled and classified areas, for example, manufacturing areas and laboratories. Viable and non-viable particulate tests are performed. Some forms of monitoring include the use of contact plates, settling plates and air samplers.

This is just a summary of some of the basic tests. There are additional tests that we will be discussed in future publications.

On the other hand, it is not only to perform the test, but after it is completed and the results are obtained, they must be documented and analyzed. It is critical, in terms of regulatory and quality systems terms perspective, to evaluate and document the data to determine if the results are acceptable or if an alert, action or the specification limits established in the procedure are exceeded. If any of these limits is exceeded, the Laboratory investigations are carried out.

It is the responsibility of Microbiology to assist in investigations related to non-conformities, deviations, out of specification (OOS), out of trend (OOT), or out of limits in the results obtained from products and environmental monitoring test. The microbiology analyst is responsible for reporting any non-compliance, initiating and / or leading the investigation efforts until resolution.

The role of microbiology in the regulated industries, such as pharmaceutical or medical devices, is very broad and critical. Decisions on the quality of a product are made based on the results obtained from the microbiology tests. It is a highly controlled and continuously audited area to ensure compliance with procedures, guidelines, standards and regulations. We encourage you to know more about microbiology focused on the area of ​​quality control. It is a very different environment as compared to what you have seen in the academy, but at the same time, you will be in a continuous learning and you will contribute a lot to the organization with the experience you acquire.



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