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Career Story: Quality Assurance Specialist For A Pharmaceutical Contractor

Quality Assurance Specialist For A Pharmaceutical Contractor

Job Title: Senior Associate, Biostatistics And Quality Assurance

Type of Company: I work for a contract research organization that helps medical device companies get products in development approved by the FDA. We assist with all phases of research, from study design/concept through clinical trials and data management, to statistical analysis and medical reporting.

Education: BS, Industrial Engineering, University of Rhode Island •• MS, Engineering Management, Northeastern University

Previous Experience: I worked in engineering at Data General until I finished my masters. Then I moved into research at the US Army Research Institute of Environmental Medicine in Natick. After that, though I continued in research, I shifted to the pharmaceutical business, where I worked for contract research organizations helping drug and medical device companies get new products to market.

Job Tasks: At work I wear two different hats, spending half my time as a programmer and half doing quality assurance.

My programming tasks include taking research data and organizing and manipulating it to produce summary tables and statistical results. These are then incorporated into reports (by someone else) so that critical business decisions can be made. They're subsequently submitted to the Food and Drug Administration, as part of new drug (or device) applications, in the hopes that the product will be approved for general use. The products I have worked on are quite varied - drugs for AIDS, skin disease, and high cholesterol; toothpaste to fight gum disease; devices such as coronary stents and filters; artificial joints; and spinal disk replacements.

My quality assurance (QA) work helps to ensure that my company, and other companies we do business with, are in strict compliance with the numerous and varied federal regulations that govern what we do. Clinical research is a heavily regulated business. The Food and Drug Administration has rules we have to follow to protect the safety of the individuals who use the drug and device products on the market. As QA, I have to know what these are. In fact, I even write procedures that other employees have to follow to comply with those regulations. I audit our work and the work of our business partners to ensure that these procedures are being followed.

Best and Worst Parts of the Job: The best part of my job is that it allows me to feel that I am doing something to help people. I know the products I've worked on that finally reach the market have been exhaustively tested and are generally safe and effective. Sometimes the products that I help develop are the only option for a particular disease or illness.

Another good thing about my job is that there seem to be many job opportunities for people with my background and skills. Drug and device companies are growing and looking for people, especially programmers and quality assurance specialists, and there are other companies (consulting companies such as my own) that need people too. Recruiters are abundant and make job searches easy. I must get calls from recruiters every week, and I never worry about what would happen if I lost my current position.

The worst part of my job is hardly even a complaint. Like any job, there are things that are unpleasant. Working under regulations is difficult. Since I am in consulting, there are client demands that have to be met and timelines that we have to adhere to. But all in all, the demands are quite manageable and the positive aspects of the work greatly outweigh the negative aspects.

Job Tips: When I first started in clinical research I didn't even know it existed. There really weren't college courses available. Now colleges offer classes in clinical research and regulations. These courses are necessary for QA, but I would recommend taking these courses even if you are interested in programming. All programming is helpful, but the product used most widely by pharmaceutical concerns is SAS. Some colleges teach this as well. But statistics courses are especially useful for programmers, helping them to understand the requirements and the programming output.

Additional Thoughts: There are many different positions in clinical research. I am limiting my answers to the jobs I've done myself, but much the same holds true for clinical monitors, data managers, statisticians, medical writers, and other occupations in the industry. Anyone who enjoys a challenge and working on several different projects at once would probably enjoy working in the contractor environment. You would benefit, certainly, from an ability to multi-task and a knack for switching directions on short notice. But people who prefer seeing the whole picture or working on a project from beginning to end would probably like the client side better. There, you're usually assigned to a particular product line and a fixed role on any given project.

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