Kierstin Meckes

As a quality control analyst, I participate in routine testing and review while maintaining compliance with GDP and GLP practices. Outside of routine testing of raw materials, finished goods, and in process materials, I continuously work on projects assigned. A part of my workload is assisting to transition to an electronic documentation system and managing corrections needing to be implemented in the system.

Some of the projects I have participated in include completing document revisions for test methods, periodic reviews of documents within the lab, technical writing of IQOQPQ reports, and method development for a new testing procedure within the lab. I have also completed documentation relating to a CAPA and received training on writing and implementing a CAPA and Change Control within the applicable database.

Throughout my time within the lab, I trained on various techniques used in the testing of finished goods, raw materials and in process samples. Instruments included in this training are GC, Karl Fischer, pH, UV-Vis, FT-IR, Density, Auto-titration, and Refractive Index. After my training was successfully completed, I went on to train peers on tests within the lab.

As a part of a GMP laboratory, I have assisted within several audits in making sure the lab is in an audit ready capacity. One major audit I participated in was the FDA audit, where I demonstrated to auditors the use of a GC software for data analysis in front of management.

While on shift, I maintain effective time planning skills and aim to communicate professionally with others. I aim to resolve problems as they arise by utilizing problems solving skills necessary.