Kaitlyn Pyrtle Email & Phone Number

Noblesville, In, Us

Nashville, Tennessee, United States

-Review batch records to assist Manager of QA with batch release activities.-Create and/or revise SOPs, batch records, and various GMP documents in support of site operations. Proofread and merge documents upon request. -Initiate document reviews in MasterControl.-Perform the connection of training to documents in MasterControl.-Adhere to company policies and applicable regulatory agencies requirements (ICH, FDA, etc.) to ensure compliance.-Support during client audits and regulatory inspections.-Communicate effectively with cross-functional teams.-Track batch cycle times and batch right first time metrics to better improve the batch review process.-Provide quality oversight on the manufacturing floor during batch production.

Bloomington, Indiana, United States

Review batch records to assist the Senior Quality Assurance Representative with batch release activities. Created and revised client memos supporting COVID-19 batches produced at the site. Assisted MS&T and clients with onboarding new equipment and evaluating new manufacturing processes from a quality perspective. Worked closely with cross-functional departments to ensure batch readiness from R&D to GMP production. Worked closely with Quality Assurance Client Services to close out client observations. Involved with deviation investigations and deviation closure. Assist with regulatory inspections.

Bloomington, Indiana, United States

Prepped all the filling/formulation equipment for the respective departments. In charge of pre and post testing all filters from formulation to ensure that sterility was maintained throughout the entire batch process. Worked closely with my lead to gain the knowledge of becoming a lead including learning how to update the prep schedule and present the shift update to current shift management as well as incoming shift management. Worked closely with our production controllers to make sure we had everything ordered up that we would need for the week and implemented better systems to ensure that components and materials would not go to waste should a batch be cancelled or pushed out for a later date.

Bloomington, Indiana, United States

Assembled medical devices for many different clients. I was a nonconformance coordinator for my line which means I was in charge of detecting any defects and then sending them away for further investigation. I was line lead for my line in charge of planning the days work and ensuring that my line had the tools and items required to get our assigned work load completed in a timely manor.