Career Strategies for Jobs in Pharmaceutical Quality Assurance

Published: Apr 15, 2014


By Alex Twersky, Marketing Consultant and Career Expert

Every industry that relies on manufacturing processes relies on a well-documented and thorough quality assurance process. This ensures that the products being produced adhere to strict quality standards, especially when dealing with products that entail a complex process and an intricate string of ingredients, like pharmaceuticals. Furthermore, quality assurance (or quality control, the names are interchangeable) is critical to guarantee that there is no corruption of the process given the interaction that drugs have with the human body. A faulty quality assurance process can lead to costly recalls, liability issues, and worst of all, human consequences.

All of this means that quality assurance (QA) is a functional area in the pharmaceutical industry that needs to be filled by qualified staff with the right stuff to ensure the process works smoothly and mistakes are avoided at all costs. QA roles are indispensable to the manufacturing process in pharmaceuticals; hence good people are always sought after, more so given the growth of the pharmaceutical industry.

Do you have what it takes to fill one of these roles in a fast-growing manufacturing environment? Here are some key strategies to prepare you for an exciting and rewarding career in pharmaceutical QA:

The Science of QA

An important part of the QA process revolves around the science, and is not that different from lab work that one may perform as a scientific researcher. Quality Assurance Analysts work in the lab to ensure that the chemical ingredients as well as the finished products themselves (for example, through stability sample tests) meet the highest quality standards at every step of the manufacturing process. To fill this role you’ll need to make sure you come equipped with the right academic and professional experience: lab research experience is a plus, and solid background in basic sciences is a must. If you’re currently pursuing a Masters degree and this line of work interests you, securing a summer research internship in a QA lab at a pharmaceutical company is also well advised, as this might be your “foot in the door” for a full-time position after graduation.

The Regulatory Landscape

If your interest in pharmaceutical QA is not lab-based, you might consider the regulatory path. Working with domestic and international regulatory bodies to document that products adhere to set standards is a big part of the QA process. This function is heavily focused on preparing submissions to regulatory bodies, reviewing results, drafting internal and external reports, and presenting to stakeholders both inside and outside the company. To prepare you for this type of role, a basic sciences background is certainly helpful, but it does not have to be as extensive as it would for a lab position. For those interested in this direction, you might consider pursuing a joint degree, such as a combined MBA and MS in Chemistry, for example, in order to solidify your scientific footing while locking in the business, communication and analytical skills you will need to navigate the regulatory landscape successfully. As the pharmaceutical industry grows, the regulatory landscape expands with it, so pharmaceutical companies will continue to be on the hunt for candidates who blend a business and science background. Opportunities in this vein also extend beyond the pharmaceutical companies themselves to specialized consultancies that advise Big Pharma on various regulatory issues, including handling submissions.

Ticking the Right Boxes

It’s not enough for pharmaceutical companies to have a QA process in place; they must be certain it’s being followed explicitly. This opens the door to opportunities for auditors, both those employed by the company itself (Internal Auditors) and independent auditing firms. In contrast to the regulatory work described above, which deals primarily with the product, auditing deals with the process. If the integrity of the manufacturing process is not maintained, it could lead to costly slow-downs and worse yet, mistakes that have human consequences. Auditors ensure the process is intact and structured as smoothly and safely as possible. If your talents lie in the process-side of things, you might consider this path. It requires a sharp simultaneous focus on the “big picture” and the little details. With a process engineering background, coupled with a footing in the basic sciences, you will be well-positioned for this career path.

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