The “Team Spotlight” series will allow you to meet one of Wells Pharma’s highly experienced experts. This professional/personal look will help you get to know who we are, and give an inside look at how our team members work to achieve our goal of becoming a market-leader in the 503B Outsourcing industry.
Theaquiata Mitchell- Vice President of Quality
What do you do at Wells Pharma?
As the Vice President of Quality at Wells Pharma, my main responsibility is to ensure that Wells Pharma adheres to all federal and state regulatory standards, by making sure that all the rigorous policies and procedures that we have developed and implemented are maintained on a daily basis.
But that’s just my main responsibility! I also manage other aspects of our overall operations, including Quality Systems and Compliance, and CAPA/Customer Complaint/Deviation investigations. The Quality Assurance team also oversees multiple internal departments, including Validation, Document Control, Vendor Qualification, and Internal/External Audits.
Quality Control is by far the most important aspect of my position at Wells Pharma, because of its importance to our prescribers and patients. Without getting too technical, this includes managing/overseeing such things as:
- Batch Release
- Receiving/inventorying raw materials
- Monitoring facility environments and personnel
- Out of Specification Investigations
- Retains
- Sample submission for Release Testing
What do you like best about working with customers/clients?
In Quality Assurance, we strive to meet or exceed customer demands. As a team, we are committed to providing exceptional customer service, by developing effective quality control systems that enable Wells Pharma to focus on what the customer needs and wants. Maintaining compliance with all federal and state regulatory agencies also allows us to help the customer.
In your opinion, what value(s) do customers gain by working with Wells Pharma?
Without a doubt, the fact that they know that all the products they receive from Wells Pharma are safe. Many of our competitors emphasize their quality, but we are truly a quality leader in the 503B outsourcing industry.
Thanks to the focus on our “5 Cs of Success,” – the foundation the company has been built upon – we provide customers with a consistent supply of high-quality medications that are competitively priced. We have worked extremely hard to implement new technologies and automation into our production processes, resulting in increased production and better quality, and this has certainly benefitted our customers.
Why are you proud to work at Wells Pharma?
Our leadership has had the vision and foresight to allocate resources to improve the overall scalability of Wells Pharma, and this has allowed us to meet customer demands while ensuring the patient receives a safe product. I’m very proud to have been a part of this process, and to see it make such a positive impact.
How do you support Wells Pharma’s mission and dedication to improving the health and safety of customer’s patients?
Quality Assurance does this in two main ways:
- By ensuring the integrity of our processes and products are not compromised. We know our role is important, and we take great pride in managing the chemists, lab techs, auditors, trainers, document control and validation personnel who are all so dedicated to providing the highest quality and safest products in the industry.
- By providing all Wells Pharma employees with the best training in the 503B outsourcing business, we have the utmost confidence in their ability to work with our customers and help to solve any problems that come along. Every employee at Wells Pharma plays a critical role not only in the success of our company, but also in helping our customers to be successful. Everyone realizes that, and takes great pride in their individual roles.
What are the biggest challenges faced by Wells Pharma and its customers in the current healthcare environment?
Without a doubt, the biggest challenges facing us today are the shortages of raw materials and drug products brought on by the COVID-19 pandemic. However, our commitment to technology, and continued hard work by our team has allowed Wells Pharma to provide a consistent supply of competitively priced, high-quality medications to our customer base. We will continue to provide the same kind of service as we move into 2022 and begin the transition to full automation of our production facilities.
What is the one lesson you’ve learned in the industry that has helped you most?
To be resilient in the midst of constant change.
Our industry changes on almost a daily basis. Being able to adapt to the change is what separates the successful companies from the rest of the competition.