Wrote training manuals, validation protocols, and SOPs for new and existing projects. Developed and implemented processes for the design and execution of the validation process.
Coordinated with project teams to develop and implement new and existing protocols. Developed and implemented training programs for data management.
Development of analytical methods, validation protocols, SOPs, and cGMP documents for compliance with USP, EP, and JP.
Assisted in writing and editing of the validation documents, including the development of the protocols, and the documentation of the analytical test methods.
Trained and mentored junior analysts on GLP and data validation projects. Provided support for troubleshooting and resolving issues. Performed data entry and statistical analysis.
Created and maintained project specific reports, including troubleshooting and data management. Developed and implemented a comprehensive and detailed report for the use of the analytical test.
Provided training and supervision to chemists, interns, and technicians in the Microbiology department. Prepared and analyzed samples, validation and data verification for compliance with GLP and cGMP requirements.
Performed analytical testing on raw materials, in-process, finished products, stability, and stability samples using HPLC, GC, and wet chemistry.
Extensive experience in writing and revising SOP's, validation protocols, and reports for the formulation of manufacturing processes. This includes troubleshooting of the instrument, and the maintenance of the HPLC.
Provided analytical support and troubleshooting for HPLC, GC, FTIR, and dissolution. Conducted method validation and quality assurance.
Performed investigations of OOS results in a timely manner and documented all corrective actions taken as necessary. Reviewed and evaluated safety reports for the department.
Trained in the use of HPLC, GC, and other instruments. Trained in the use of various computer programs.