Internship Reflection: Importance of Quality Compliance

As I continue to work with Amgen, I have gained a lot of knowledge in such a short amount of time. Though this is not something that has a direct relation to my undergraduate degree as a Biological Sciences major, I have also used the skills and advice I have learned as a student and research associate throughout my internship so far. Working as a Quality Systems intern, I did not expect much of a connection between academics and my current projects as Quality Compliance is not a field of study that is covered in my curriculum. The three projects I am currently working on do have the same basic foundation as my academic and research work, the most important being organization and diligence. Working as a research associate has also helped me understand how to interact with professionals across different disciplines. My experience as a student helped me reach out to other staff members, especially when there was confusion or necessity of clarity on my end. I am excited to be able to continue learning at my internship and apply what I have learned to academia this upcoming fall.

I hope to gain a stronger understanding of biotechnology and how different aspects of the pharmaceutical industry supplement the processes involved in biotechnology. Even though I work in Quality Compliance, I have had some opportunity to gain a greater understanding into other departments such as Regulatory Affairs, Process Development and Manufacturing. Having met with managers in these departments, I have started to get a better understanding of how the clinical trial aspect and lab aspect of biotechnology relate to each other. I plan to meet with more managers in different departments to strengthen this understanding.

Quality Compliance is a very important part of drug development. It ensures that the process by which drugs are created in the laboratory or manufacturing plant is standardized, safe and efficient so that the patient is served with the best quality. Companies are required to comply with the rules set by the FDA. It is important to keep these rules and regulations as up to date and accurate as possible to ensure that the quality of medicine is high. As a Quality Systems Intern, I am working on standardizing processes to ensure that subject matter experts (SMEs) are prepared for inspections and audits that arise throughout the year, which is a big part of compliance. This relates to my personal life as I have many family and friends who take medication daily; it is important that the medication they are taking is created by following standard operating procedures (SOPs), leading to high quality medication. In regards to my professional aspirations, working in Quality Compliance gives me a great insight into manufacturing (using biotechnology practices) as the two are very closely linked. This exposure will help me solidify which sub-field of biotechnology I would like to study further.

I am very excited for the remainder of my internship with Amgen. I have had a great few weeks so far and I know I will continue to learn more, which will help me reach my professional goals.

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