Latosha Fields Email & Phone Number

Covington, Georgia, United States

● Organize GMP data, documentation, and presentation materials for assigned projects ● Review documentation in Automation Control Systems, Electronic Batch Record, and/or PI Historian● Lead problem solving and Root-Cause Analysis sessions with Quality, Engineering, Manufacturing, and/or Technical Services for Manufacturing Triages and Investigations● Project management of complex investigations using DMAIC tools● Identify and implement Corrective/Preventive Actions to improve yield, reliability, and/or process robustness ● Complete documentation of investigational findings using Track-Wise system

Memphis, Tennessee, United States

● Performed quality review and approval of Deviations, Exception Reports, and OOS/Investigation reports submitted from Manufacturing, Operations, and Quality Control● Performed Root Cause Analysis for OOS results and/or excursions● Participated in cross-functional teams to identify effective CAPAs● Trained QA, QC, and Operations personnel on Quality Management Systems (QMS) and procedures● Conducted internal audits of processes, systems, and procedures● Participated in external audits and inspections● Wrote and reviewed SOPs and protocols to ensure compliance with regulatory agencies (FDA, DEA, and OSHA) and State Pharmaceutical Boards

Huntsville, Al

• Perform physical and chemical analysis of incoming finished products, stability samples, raw materials and cleaning validation/verification samples using UPLC, HPLC, UV/Vis, FTIR, Karl Fischer, Dissolution, and wet chemistry testing• Perform troubleshooting, routine maintenance check, and calibration verifications on various instrumentation• Analyze, process, and review UPLC and HPLC chromatographic results using Empower III and LIMS software• Perform non-routine method validation testing and execute method transfer protocols • Perform troubleshooting and initial investigative work related to OOS and/or OOT results• Write, review, and/or approve SOP’s, methods, and protocols using MasterControl• Write and approve OOS, OOT, and NOE investigations using TrackWise• Review laboratory notebooks, reports, and COA’s for accuracy• Train new and junior chemists on laboratory instrumentation, software, safety, and proper chemical waste disposal• Continuously drive improvement initiatives within the laboratory pertaining to 6S organization

Kansas City, Mo

• Performed routine and non-routine analytical testing using HPLC, LC/MS, UV/Vis, and Karl Fischer• Performed HPLC and LC/MS analysis of clinical and preclinical samples• Ensured compliance with SOP’s, GLP, and regulatory agencies (FDA, DEA, MHRA, EHS, OSHA, etc.)• Participated in OOS/OOT investigations and recommended corrective/preventative actions (CAPA) as needed• Conducted method development and method validation• Participated in cross-functional and departmental teams on projects regarding safety, compliance, and quality• Recorded data and GMP documentation in an accurate and timely manner• Performed peer review of chromatography, reports, and laboratory notebooks

Columbia, Mo

• Performed complex pharmaceutical experimentation and method validation using HPLC, Dissolution, TLC, and wet chemistry techniques according to methods, protocols, and SOP’s• Performed and maintained instrument calibration• Responsible for the quality and accuracy of data recorded in laboratory notebooks and reports • Performed review of BPR’s and other documentation pertaining to manufacturing

Gainesville, Ga

• Analyzed raw material samples according to USP/NF monographs and established methods using FTIR, UV/Vis, TLC, titrations, and viscosity• Analyzed in-process, stability, and finished products using HPLC, UV/Vis, Dissolution, and wet chemistry• Documented laboratory data following GLP and GMP regulations• Responsible for writing and revising In-house methods and SOP’s• Participated in laboratory housekeeping and instrumentation maintenance

Master Of Science (Ms), Pharmaceutical Sciences

Bachelor Of Science (Bs), Chemistry