I am a Quality Specialist III at our St. Louis, MO site.
What is the most rewarding part of your job?
Providing guidance and advice to the lab to ensure decisions and actions are made in a compliant manner. In addition, trying to provide the lab with the most efficient processes to follow while still maintaining a state of compliance.
What are your team's latest achievements?
We have completed Phase 1 of the laboratory move from our previous site on Lindbergh Ave. to our new site in the Cortex Innovation Community. We are currently in the middle of the Phase 2 move of equipment while continuing to keep QMS in a state of control with CAPAs, lab investigations, deviations, etc. closing on time.
How do you see those accomplishments affecting the pharmaceutical industry?
As we move to the new Cortex site, we are re-establishing baseline qualifications of all equipment as well as performing full software validation on stand-alone instruments. These steps will enhance the compliance of the site and ensure the data integrity for testing being conducted. In addition, what we are doing here can help our sister sites as well.