Emergent BioSolutions Expanding
Quality Assurance Team
Quality assurance is a key function in the biopharma industry that provides a hands-on role in day-to-day operations. It’s a role that allows team members to maintain their fingers on the pulse of the beating heart of a drug manufacturing company. And it’s a role that’s available at one of the biggest drug manufacturing companies in the BioHealth Capital Region.
Emergent BioSolutions is expanding its QA team to ensure its drug manufacturing capabilities maintain the highest levels of professionalism. The company is looking to rapidly expand its QA team as it heads into the new year.
“This is a company where you are encouraged to find a better approach and solution to existing processes. There’s never a dull moment here. You’ll be challenged and rewarded,” said Chris Hartstein, who joined the company in April 2021.
Hartstein joined the company after spending several years at a California-based biotech supporting their QA function. He joined Emergent as an Analyst II and based on outstanding performance was interviewed and promoted to a supervisor role after eight months. In his role at Emergent, he manages a team responsible for overseeing batch record review, daily audits, and conducting walkthroughs to ensure compliance. He provides a daily summary and he and his team author deviation reports.
Although he transitioned from a similar role, Hartstein said at Emergent he has been exposed to new systems and procedures that have expanded his skill set.
“I’ve learned a lot that I didn’t previously know,” Hartstein said.
The expansion of the quality assurance teams comes months after the company navigated through a difficult period. Early this year, a single batch of COVID-19 vaccine drug substance was cross-contaminated. Emergent has taken full responsibility for this incident and addressed the conditions that caused it. With the dedicated work of its employees alongside their partners, manufacturing was resumed in late July.
Bradley Tippett, who was recently promoted to the role of manager of Emergent’s QA Batch Release Program, pointed to the rigorous standards the company has in place. At this point in time, Tippett said there are approximately 100 million dose equivalents of COVID vaccine that “are out in the world.” He added that his QA colleagues from the company are dedicated to continuing to deliver quality products.
“This is the place to come if you want to make a difference. We come early and stay late because we know how important it is,” Tippett said. “Everything we do we do to help people.”
Alexis Mincolelli, a Quality Assurance Analyst at Emergent, initially applied for a manufacturing role. However, she was encouraged by the company to seek a role with the QA team. Mincolelli now works at the company’s Bayview facility and oversees batch records and personnel.
She noted that QA roles can mean different things at different organizations. At Emergent, the QA team provides oversight of multiple departments within the company.
“We get a taste of everything. There’s a bit of spice to our jobs,” Mincolelli said.
When Mincolelli was first hired in 2020, Emergent was in the process of building a new “Quality-on-the-Floor” team. She said it was exciting to be part of something new that could challenge her and allow her to increase her skills. Like the company, she was forced to adapt to the setback Emergent experienced, but she said it made her and the company stronger.
“There’s a lot of opportunity to learn about the industry, build upon successes and learn from mistakes,” she said. But through that difficult time, she said the company was able to take a collective breath and address those issues. “This was an all-hands on deck time.” New members of the Emergent QA team will help ensure that production remains on track and is of the highest quality.
Tippett described the role of the QA team as something akin to a parent. He said it’s a teaching role where he and his colleagues have an opportunity to guide team members through regulatory requirements in order to ensure that the highest standards are being met.
Looking back on her own tenure at the company, Mincolelli said she has loved the challenges of new projects and new processes. She said the experience she has received in 18 months has been incredible and rewarding. Over the course of those 18 months, Mincolelli has learned how to handle multiple tasks that have equipped her with the skills to take on new opportunities within the company that could take her career to new heights.
Like his colleagues, Hartstein noted the numerous opportunities that can be found at Emergent. He said it’s an exciting place to work that provides significant challenges and rewards.
“I’ve learned more in the six months that I’ve been here than in years in my other job. The sky is the limit for growth,” Hartstein said. “You’re going to learn, and your career will definitely grow. You’ll learn something here that could have taken you years to know somewhere else.”