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Career Story: Senior Quality Auditor For A Large Biotech Company

Senior Quality Auditor For A Large Biotech Company

Job Title: Senior Quality Auditor

Type of Company: I work for a large biotech company which develops many different therapies for different diseases.

Education: BS in Cell and Molecular Biology, University of Michigan •• MPH in Epidemiology and Biostatistics, Boston University School of Public Health

Previous Experience: I worked at Dana Farber Cancer Institute as a study coordinator for lymphoma clinical trials. As a study coordinator, I helped oncologists to run clinical trials and test out new possible treatments that haven't yet been approved by the FDA. I collected information from the patients and wrote them on forms that were sent to the company developing the drug.

Job Tasks: Let me briefly explain how drugs get approved in the US. A new drug is created in a lab and then tested on animal models first. If it works on the diseased animal, then it'll get tested in humans. Clinical trials are run throughout the world on humans with the disease. The data is collected and then analyzed. Then, if the drug works, the data is submitted to the FDA and they will decide whether or not to approve the drug. If the drug is approved, my company can sell the drug.

My company has many clinical trials in process throughout the world. I travel to hospitals, clinics, doctors' offices that are running our studies. What I do is I review the medical charts, and all data generated and make sure that the data collected is correct. I make sure that the doctors are following the written protocol and that patients are getting the correct dose. Also, you want to make sure that the patients are real - that doctors aren't faking the data. To do this, you look at handwriting samples of the patients, look through for insurance information, make sure everyone has a reasonable birthday (for example, a 30 year old person should not have a birth year of 2000), sometimes you can look at the doctors' appointment logs. Overall, I have to make sure that doctors are following the proper procedures in running their studies. There are laws by the government, the FDA, that doctors must follow if they want to run a clinical trial.

Best and Worst Parts of the Job: Best part of my job is that I feel that I am doing my small part to help out the world. If I audit a study that's testing drugs on babies whom will otherwise die if they don't get treated and the drug works, there is some satisfaction in knowing that what my company does is saving some lives.

The worst part of my job is the bureaucracy. A lot of people are political or just big talkers. If I have issues on my audits, it takes a long time for the people at the top to hear it.

Job Tips: I'd recommend being a study coordinator at a hospital that runs clinical trials. Take GCP (good clinical practice) courses. Being a study coordinator doesn't pay well, but the experience of understanding how clinical trials are run are priceless. Then, apply for entry level jobs in Quality Assurance or Compliance at biotech or pharmaceutical companies. It's took me about five years to get to a corporate company.

Additional Thoughts: The most important attribute to have in this job is to be very detail oriented. The data collected and analyzed is very important. You don't want the drug to hurt people or cause bad side affects later on so paying attention to everything really helps.

If anything, I wish I had known earlier about clinical trials. My Master's degree is not necessary for what I do but it does help a little and it does get you a better salary.

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