Within drug development, QA is split into many departments. One department is called Floor Support QA and these workers are in charge of managing and reviewing batch records or written process instructions that are performed by the manufacturing associates/scientists as well as writing change controls and approving document changes. Production Support is another QA role and these employees are in charge of creating these batch records or written instructions while working with the clients to make sure that the instructions are in compliance with their process standards. Within the field I have chosen, I think I would lean more towards working in Production Support rather than Floor Support since I have more of a say in what the instructions would entail for the Manufacturing Associates/ Scientists and I would be able to get a clear idea of what the process would be comprised of so that I can make sure that the process would be in compliance with the FDA as well as the company standards. I would rather be in a more hands-on position especially because I would enjoy listening to the process and what the intended target is for the process. Since I also have experience within the scientist position, I think I would have a better understanding of what is allowed in the cleanrooms/ labs as well as how certain pieces of equipment function so that I could offer some insight to the clients as well. 

Then within QC, the two departments that I am knowledgeable about are QC Analytical and QC Environmental Monitoring. QC Analytical focuses more of performing data analysis testing for cells counts, viability and pH. QC Environmental Monitoring focuses more on how aseptic the Manufacturing Associates are while processing in the cleanroom and to make sure that there isn't any bacterial growth or particulates within the cleanrooms. Out of these two departments, I think I would rather go into QC Analytical since it is more lab experience and will offer more opportunities for learning all the different types of cell count equipment. 

A role that is available in quality management systems is a quality assurance test engineer. A quality assurance engineer identifies errors within the software using a test before a product is set to launch. The primary responsibility of a quality assurance engineer is to prevent defects, they are responsible for finding and eliminating mistakes in code that could stem from many issues such as insufficient data input or unsuitable designed interface elements. Quality assurance engineers work alongside design engineers to fix errors in products. Some of the qualifications include a BS/MS in engineering (or a related subject), work experience in software development, knowledge of SQL and scripting, knowledge of quality assurance software methodologies, and hands-on experience with testing tools. Personally, a quality assurance engineer sounds like an interesting job that could expose me to a lot of different elements of engineering that could build on my skills, so it would be a career I would consider.

A career in quality management can be lucrative depending on the approach. This field focuses on controlling, ensuring, and improving quality in business productivity and operations. It checks that the organizations, their products, and services are not changing. In other words, it is where you are working to make organizations better. It is also focused on efficiency, reducing risk, dealing with compliance, solving problems and employing process improvement tools like Six Sigma. It pays off working in quality management because you can move from sector to sector. You can work with everyone and using your quality assurance skills, support them in achieving goals that you have set. Later on, if you wish yo can set you own business.

I am currently a Quality Systems Technician at Theragenics. They also call us QAs. Theragenics is a corporation that manufactures and distributes medical and surgical equipment for brachytherapy. We verify a lot of things within the operation to make sure everything is of quality. For instance, I check to make sure paperwork is correct and filled out completely. I also double check the work that the laboratory technicians produce. I make sure things are sterilized properly, I make sure packaging is correct, I make sure measurements are correct, I make sure inspection is done properly just to name a few. I have to make sure everything follows protocol and guidelines before the items are shipped out to the customers such as doctors and patients. Paying attention to detail is crucial for this position, but I enjoy my job.

One role in quality management is a Quality Assurance (QA) Specialist. A QA Specialist is responsible for ensuring that products or services meet established quality standards and requirements. They work to identify and prevent quality issues, and ensure that corrective actions are taken when necessary. The qualifications for a QA Specialist may vary by industry, but generally include a bachelor's degree in a related field, such as engineering or science, and experience in quality management.

Responsibilities of a QA Specialist may include developing and implementing quality policies and procedures, conducting audits and inspections to ensure compliance with regulations and standards, analyzing data to identify trends and opportunities for improvement, and collaborating with other departments to resolve quality issues. They may also be responsible for training employees on quality procedures and best practices.

I could not see myself doing this job.  I would want to be the one doing the work and have the Specialist come and check on me.  I am a more hands on person.

Quality management systems (QMS) are fundamental to ensuring that products and services meet specified requirements and standards. Within the QMS, there are various roles spanning from low to high levels, each dedicated to ensuring and controlling quality. For instance, a Quality Assurance (QA) specialist works on developing and executing quality systems, making certain of compliance with regulations, performing audits, and directing corrective and preventive measures. In contrast, Quality Control (QC) professionals emphasize assessing product or service quality via inspections, testing, and analysis. Meanwhile, roles in Document Control ensure proper creation, revision, and management of all quality-related documents. There's also an essential focus on Training, where specialists create and offer training programs to ensure staff understand and adhere to QMS requirements. Additionally, Complaints Management plays a crucial role in addressing customer complaints, investigating incidents, and implementing the necessary corrective actions. Further, given the increasing emphasis on compliance and meeting regulatory requirements, the role of a Regulatory Affairs Specialist stands out. These specialists are on the front line, ensuring that products are compliant with all regulations. Their responsibilities are vast, from understanding legislation to giving strategic advice on new product development. For anyone with a background in Biomedical Engineering, such as myself, this role is particularly pertinent. With a solid grasp on the medical device industry and associated regulations, combined with our analytical prowess, we can bridge the gap between the technical and regulatory realms. With my qualifications, I could envisage myself contributing significantly by reviewing and evaluating the integration of new medical technologies within regulatory frameworks, ensuring they meet global standards while driving innovation.