Entry Level Job Titles
- Microbiology Technician
- College Diploma (entry level)
- Microbial testing
- Sterility testing
- Environmental monitoring testing
- Assay test
- Other tests
- Microbial testing is performed to asses the microbial quality of a product.
- The microbial quality of a product may include testing for (presence/ absence of) microbial load, specific organisms, and/or endotoxins.
- The sterility testing of a product assesses the sterilization processes of sterile products such as injectables and medical devices.
- Environmental monitoring testing assesses the microbial quality of the air and the surfaces of a manufacturing facility.
- If working for a contract lab, you will have to travel to the client’s facility
Assay tests verifies the label claims of pharmaceutical dosage forms such as antibiotic creams and ointments.
- Using a dilution scheme of a known standard, you will compare the inhibition of growth to sample and extrapolate the sample concentration based on zones of inhibition or turbidity of bacterial growth.
- Identification of organism growth
Proper documentation and record-keeping following Good Documentation Practices (GDP).
Must Have Skills
- Attention to details and ability to follow written procedures without any deviation
- Testings must be adhered to regulatory guidelines, test methods and Standard Operating Procedures (SOPs), therefore, attention to details is very important
- Review of paper work thoroughly
- When reviewing, checking that lot/batch# match up and the correct methods are used is very important
- Good documentation practices
- Honest and transparent
- Able to calculate and perform dilution
- Often you will have a known concentration of organisms (such as 2.2 x 10^6 CFU) and you will be required to obtain a sample solution such that when you plate 1mL, the plate will ideally be within a countable range of 30-300 CFU.
- Since microscopic organisms are not visible to our eyes, understanding of the concepts and knowing which steps or factors may create a risk will be considered valuable
- Work well under pressure and in a ‘fast paced and minimal tolerance for mistakes’ environment.
- Able to work in a highly regulated industry by following company procedures and regulatory guidelines
- Able to take responsibility for your own action. Work well individually and as part of a term. Professional, fast learner and takes initiative
Type of companies that hire
- Pharmaceutical/ Biopharmaceutical
- Regulatory Agencies (Health Canada, FDA)
- Contract Labs
- Cannabis Industry
- Food Industry
Any transferable skills that speak for your ability to follow instructions and written procedures without any deviation
Microbiology Technician –> Microbiologist –> Senior Microbiologist –> Supervisor –> Manager
–>apply to the country’s regulatory agency for a related position.
- If Canadian and interested in a government job:
- Health Canada
- National Microbiology Laboratory
–>if you are an expert in the field, become a consultant
->if you are an expert in the field and have M.Sc./ Ph.D., teach at a college that offers course on this field.
–> if you have certification on project management and preferably PM certified, consider becoming a Project Manager
–> with business certification, you could even transfer to business side of the pharma
- Pharmaceutical Microbiology Manual (FDA, 2014)
- USP <1117> Microbiological Best Laboratory Practices
- USP <1029> Good Documentation Guidelines