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Career Story: Pharmaceutical Quality Assurance Specialist

Pharmaceutical Quality Assurance Specialist

Job Title: Pharmaceutical Quality Assurance Specialist

Type of Company: My company develops and manufactures life saving drugs which dramatically improve the lives of our patients.

Education: BA in Molecular Biology/Biochemestry, Middlebury College •• MS in Pharmaceutical Regulatory Affairs, Northeastern University

Previous Experience: Prior to this job, I worked in Quality Assurance for two medical diagnostic companies.

Job Tasks: My company manufactures drugs for use by patients around the world. My primary responsibility is to release each batch of drug for distribution to those patients. Since patients depend on these drugs, it is absolutely critical to ensure that the drug is effective (that it is what we say it is and will do what we say it will do) and safe for use (that it will not cause more harm than good). This release is based on review of manufacturing and testing documents for each batch as well as an understanding of government regulations. (Pharmaceutical manufacturing is very heavily regulated by the Food and Drug Administration (FDA) as well as FDA-equivalent regulatory agencies in other countries.)

In addition to product release, I also work on a number of other projects. I play a role in the transfer of new or improved products from development facilities to commercial manufacturing sites. I assist with investigations when manufacturing or testing deviations occur to determine what went wrong, how we can ensure it won't happen again and whether the impacted product is suitable for release. I ensure that intended or unintended changes to the manufacturing and testing processes do not impact product quality.

This may sound like a lot, but, ultimately, my main goal is ensuring that effective and safe products are available to the people who need them, when they need them.

Best and Worst Parts of the Job: The best part of my job is knowing how much what I do helps my companies patients. On occasion, the company has someone taking on of its drugs come in and explain what the drug means to them. It's very inspiring to see what a difference my work makes in people's lives - without me, they may not receive the drugs they need.

Job Tips:
1. While a background in science is important, expect to learn a lot on your first job.

2. Ask a lot of questions. Knowing how to do something is good, understanding why it is required and how it fits into the bigger picture is much better!

3. Most people arrive in quality assurance after working in other jobs, such as manufacturing or quality control laboratory testing, in the same industry. Don't be discouraged if you have to do the same.

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