Madeline Applegate Email & Phone Number

Kansas City, Missouri, United States

Columbia, South Carolina Area

Performed microbial bioburden testing on controlled substances, in-process compounding samples, BFS samples, raw materials, and Water For Injection samples with the use of a Sartorius Manifold. Performed dilutions on raw materials for testing purposes. Isolated pure cultures of bacteria for identification purposes. Prepared microscopic slides with various organisms for identification purposes. Completed gram stain and lactophenol cotton blue stain analysis on various organisms. Documented cell… Show more Performed microbial bioburden testing on controlled substances, in-process compounding samples, BFS samples, raw materials, and Water For Injection samples with the use of a Sartorius Manifold. Performed dilutions on raw materials for testing purposes. Isolated pure cultures of bacteria for identification purposes. Prepared microscopic slides with various organisms for identification purposes. Completed gram stain and lactophenol cotton blue stain analysis on various organisms. Documented cell morphology on numerous organisms. Performed catalase and coagulate (bactistaph latex kit) testing on a number of organisms. Identified organisms with the use of Bruker Maldi-tof. Tested PH on raw material, buffers, agar plates, WFI, etc. with the use of a Mettler Toledo. Incubated, enumerated, and verified agar plate samples collected from laboratory testing and environmental monitoring. Continuously observed BET, rapid sterility, 14-day sterility, growth promotion, and particulate matter testing. Utilized LIMs (Laboratory Information Management Systems) and MODA EM / MODA FDC to collect and receive numerous samples including in-process samples, stability samples, raw materials, finished product samples, and controlled substances. Investigated and closed excursions present through out the facility pertaining to microbiology data. Observed and performed Method validations on lab procedures. Performed waste destruction for all samples including controlled substances. Followed and practiced cGMP, GLP, and SOP regulations/standards. Continuously trained new employees on LIMS/MODA use, all current lab procedures/tests, and other job duties. Show less

Columbia, South Carolina Area

Continuously used aseptic technique while collecting and performing all sampling procedures. Collected viable surface samples, viable/non-viable air samples, and personnel monitoring sampling. Collected BET, TOC, and Bioburden samples on Water For Injection, clean steam, and feed water. Collected the air pressure, temperature, and humidity to ensure that the clean room environments were within specification. Completed quarterly clean room inspections. Performed sterilization of equipment with… Show more Continuously used aseptic technique while collecting and performing all sampling procedures. Collected viable surface samples, viable/non-viable air samples, and personnel monitoring sampling. Collected BET, TOC, and Bioburden samples on Water For Injection, clean steam, and feed water. Collected the air pressure, temperature, and humidity to ensure that the clean room environments were within specification. Completed quarterly clean room inspections. Performed sterilization of equipment with the use of an autoclave. Incubated and enumerated agar plate samples for growth. Utilized LIMS (Laboratory Information Management Systems) and MODA EM / MODA FDC to collect and receive numerous samples. Followed and practiced cGMP, GLP, and SOP regulations/standards Continuously trained new employees on LIMS/MODA use, all current lab procedures/tests, and other job duties. Show less

Newberry, South Carolina

Created controlled documents for the continuous documentation of Data. Generated and Organized clear Standard Operating Procedures for processes performed within the laboratory as well as processes performed within the manufacturing side of the facility. Created a System to control and organize the numerous amounts of documents and procedures within the facility. Communicated with the entirety of the facility to notify when documents had been updated or altered to fit the companies needs… Show more Created controlled documents for the continuous documentation of Data. Generated and Organized clear Standard Operating Procedures for processes performed within the laboratory as well as processes performed within the manufacturing side of the facility. Created a System to control and organize the numerous amounts of documents and procedures within the facility. Communicated with the entirety of the facility to notify when documents had been updated or altered to fit the companies needs. Continuously found ways to improve MacLean Power Systems in order to fulfill the needs to be ISO certified. Show less

Bachelor Of Science - Bs, Pre-Medicine/Pre-Medical Studies

Activities and Societies: Kappa Delta - Delta Mu, Newberry Cheerleading, Future Medical Professionals, Tutoring

Associate Of Arts - Aa, General Studies