Kyle joined the company as a pharm dev operator. The position appealed to him as a way to learn the overall manufacturing process of tablets and capsules from dispensing to packaging. He later stepped out of his comfort zone to work in QA Analytical, which he believes broadened his understanding of what happens after the manufacturing process and what goes into product testing. Eventually he transitioned to a position in QA Pre-commercial Manufacturing where he serves as a specialist.
What is your role?
Quality Assurance Specialist for Pre-commercial Manufacturing
What area of work is your specialty or strongest focus?
My focus is the Quality Assurance review of Pre-commercial Batch Records, controlling the storage and inventory of QA retains and completing in process room check-ins. Retains are logged into what we call the tracker. I verify the data is input correctly and it matches the retain at hand. I then log them into our QA retain inventory database for storage and location tracking. We have improved this process from how much information is captured for the initial logging of the retain to how they are stored in the warehouse for easier tracking and identification. Destruction of these retains is still a WIP but we hope to have a system finalized soon.
What are you currently working on, project-wise?
I’m looking at ways to improve the process of logging, tracking and destruction of precommercial QA retains.
What is the most rewarding part of your job?
I enjoy collaborating with other leaders and building upon knowledge as well as accepting and conquering challenges. I also enjoy mentoring colleagues.
Describe any challenges you’ve found in your job and how you’ve addressed them.
Identifying the most efficient and effective strategies when met with barriers and challenging situations. Often we find ourselves with our backs against the wall, through no fault of our own, to meet deadlines and complete task in high priority situations. We simply do the best we can with the situation and information at hand to make the best decision. Rush requests have become a somewhat normal expectation.
How do you think your work (or type of work) might impact the contract pharmaceutical industry and the industry at large?
The responsibility of this role is to ensure quality pharmaceuticals are produced correctly. These products, clients and clinical trials affect people and have the possibility to become commercial products for the majority of people to have access to.
What is the best piece of advice you ever received from one of your mentors/colleagues?
A wise man once told me “I’m not working as hard today as I did yesterday.”