Quality Matters – The Career Journey of a Pharmaceutical Quality Assurance Representative

Quality is one of those words people might argue over, but we’d all agree we know it when we see it. In the world of life sciences, assuring quality is almost always a life-or-death issue. Today, few other industries are transforming as fast and as fully from the effects of intelligent machines and automation than bio-technology, pharma and the medical devices world.

Yet, even as the machines are in ascendancy in these early days of the fourth industrial revolution, [see our Working in America deep-dive exploration of this fourth revolution] we know that professionals with deep skills of quality assurance are more mission critical than ever. We spoke with one of these new-tech professionals working in the life sciences industry to get her take on the current state of the art of quality assurance in the era of the machines.

From concert hall to clean room

Today, Shae Redfield is a senior quality assurance representative in the bio-tech field. But, right up until her sophomore year in college, Shae knew she wanted a career as a concert pianist. “I actually started at Indiana University as a piano performance major, and that’s what took me to Bloomington originally. I worked hard and trained for it from my earliest years. Then my sophomore year I changed my major and ended up getting a biology degree and piano became a hobby.”

“One of the things about being a musician at the level I was trained at, is your brain gets very used to performing at high levels of critical thinking and creativity. One of the more interesting things I realized pretty quickly was that, in this field, that same sort of human brain power comes in handy every day.”

First gigs matter

For someone who had her sights set squarely on a career in music and concert performance, we were curious to hear Shae’s story about how she navigated her job search and career building after graduation.

“It wasn’t easy for the first few years. Like a lot of my friends and peers, after graduating with my degree I waited tables while looking for my first job break. In my case, it was four long years of waiting tables. Then in 2011, Justin Dragoo from Actalent reached out to me with an entry-level opportunity working in a lab. It was a job washing laboratory glassware and equipment. I jumped at it, and it turned out to be the perfect entry point I needed into this industry.”

People watching at the revolution

One of the defining characteristics of the fourth industrial revolution underway is the various industrial applications of machine intelligence to drive new forms of automation. In a category like bio-tech pharma, the revolution is affecting everything from how products and therapies are designed and developed, to their manufacturing process and how they operate as connected devices for the patients they serve.

In some industries, there remains a concern as to whether all this hyper-automation and machine intelligence was eliminating more jobs than it was creating and wondered what Shae thought.

“I don’t think it’s removing more jobs than its creating. I’m a quality assurance specialist and I’ve seen several major changes in the past five years. The first is how automation is raising the quality standards by a huge factor. We once had people manually evaluating microbial and particle contamination levels on lab equipment to assure that a totally sterile environment was maintained. When people do this, there is always some margin of error. We’ve practically eliminated this by implementing clean-in-place sanitization systems, electron irradiation decontamination and particle monitoring systems.”

“Another change is, we’ve created a new layer of humans whose job it is to manage and monitor those machines which, in some cases, have replaced more manual jobs. Finally, there are people like me — the quality assurance management layer who watch and oversee the people managing the machines.”

When it comes to the accelerating growth in the bio-tech and pharma industry, Shae was equally positive. “When I joined the team in our facility, there was 400,000 square feet open and waiting to be filled. In this year alone, we’re adding 100 more jobs. From my perspective, the life sciences industry is growing.”

Quality matters: saving and prolonging lives

Speaking with Shae we couldn’t help but notice her powerfully contagious sense of passion for her work and her field.

“There’s just so much happening in my company. We’re working on products and therapies that are directly injected into patient bodies, so quality assurance in guaranteeing a completely aseptic work environment is critical. The speed with which we work, especially in the life-saving area of research and development, supported by all this advancing automation, is absolutely incredible,” Shae said.

“Much of the work we do in my group is around oncology therapies, and we are extraordinarily patient-focused in everything we do. It really makes you feel good to be connected in such a real way to saving and prolonging people’s lives in the work you do!”

The human factor

We wondered if Shae felt that somehow, her musical training prepared her for a career in life sciences. “Definitely. A big part of quality assurance is about assessing systems and making improvements. It’s a continuous critical thinking exercise, a heavy reliance on cognitive brain power. It’s the human problem solving factor, something, so far I think, machines don’t do as well as humans.”

“When I think about the skills I acquired and honed as a classical pianist — an obsession with detail, of deep concentration, focused work and multitasking — I realize these skills are the same ones I rely on in my job in quality assurance. In my experience, music and science have a lot more in common than some might think.”

We asked Shae if she missed playing music and she told us that music was still an important part of her life. “When I come home from a tough day in the lab, I love to relax by playing Chopin nocturnes.”

Next generation advice

"Given Shae’s unique career path, we asked if she could offer any words of advice to young people starting out today, whether in music, science or anything in between.

“I would say, from my experience, the life sciences industry offers huge opportunities for career satisfaction and growth. The sky’s the limit. But you need to be smart about what you want to do, and pursue it with a passionate commitment. In those first years after college, I still waited tables at night even after landing my entry spot in the field I’m excelling in today. I would tell students and new grads to network, network and network.”

We asked Shae whether she felt the changes being fueled by the gathering revolution in intelligent machines in the workplace was opening up more creative opportunities in new careers even as they replaced some traditional jobs.

“Yes, I really do. Technology is everywhere. Which is why I also would say to those who worry about kids being overly involved with their phones and apps, ‘Give them all the technology they want — they’re going to need it!’”

Clearly, Shae Redfield has a lot of savvy insight about the work and opportunities in the growing world of life sciences. If you think and work like Shae, we’d love to work with you too. Please check our current opportunities and if you haven’t already, we invite you to create your free Actalent career account today.