Reviewed notebooks for Data Integrity Reviewed and Evaluated Methods for compliance with USP and ICH validation elements and specificationsReviewed Method Validation Protocols for compliance with USP and ICH element validation requirementsReviewed electronic HPLC trial injection data in Empower for any irregularities

Reviewed IQ, OQ, PQ validations of HPLC, GC and Dissolution InstrumentsReviewed Calibrations of HPLC, GC and Dissolution InstrumentsAudited Pilot Plant manufacturing areas for cGMP complianceEvaluated Company Products for compliance with the USP Heavy Metals requirements and documented the results in a report

ALKUConsultant for a biotechnology company in Indiana, validation, test method and protocol writing and execution on the bench. for method transfers. ValidantSubject Matter Expert, reviewing laboratory analysis data for manufactured products for a biotechnology company in Italy LTS Scientist/Consultant For a Generic Pharmaceutical Company in San FrancisoSpecifications Review / UpdatingMethod UpdatingChange Control CreationMethod Validation ConsultantGAP Analysis for Analytical MethodsProtocol Writing for Dissolution, Assay, Related Compounds, USP methodsReport Writing for Dissolution, Assay, Related Compounds, USP methodsMethod Troubleshooting

• Method Development and Validation of Cleaning Methods for several Peptide drugs and Proteins. • Sampling and Analysis of Cleaning Samples. • Assay and Dissolution analysis of Stability Samples for Peptide Drug tablets. • Method Development and Validation for a surfactants and actives in enteric tablet drug products containg peptides and proteins. • HPLC troubleshooting, maintenance, calibration and repair. • Size Exclusion Method Development and Validation for aggregates of a Peptide Drug product. • Calibration and maintenance of Dissolution Baths.Reason for Leaving: Staff Reduction

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• Method Development and Validation for Assay, Related Compounds, Dissolution, and Cleaning Validation of Generic Drug Products from researching methods to bench work. • Method Validation Protocol writing, execution, and Report writing for Assay, Related Compounds, Dissolution and Cleaning Validation of Generic Drug Products.• General Lab administration: sample tracking, supplies ordering and administering hazardous waste disposal program. • Instrument maintenance, troubleshooting and calibration. • Stability Sample analysis and summary report writing. • Creating SOP’s to set up a new CGMP laboratory.Reason for Leaving: Department Closed

Associate Scientist in Central Stability Laboratories, performing test methods on stability samples for Assay, Impurities, and Dissolution using HPLC instrumentation.

• Developed, wrote protocol, executed and wrote validation report for Cleaning Methods.• Analyzed cleaning validation samples. • As supervisor designee, conducted Investigations and wrote reports for OOS results.• Performed stability analyses and documentation work for 3 ANDA submissions in 6 months as a member of a team, after the staff was reduced by 75%.• Wrote and executed IQ and PQ protocols for Laboratory equipment.• Administrator for Empower Chromatographic Software.Reason for Leaving: Department Closed

• Performed, developed and validated GC, HPLC, FTIR, UV/Vis, TLC and wet chemical Q/C analyses of raw materials, research projects and products related to the cosmetic, and personal care industry. • Wrote SOP’s for calibration of HPLC, UV/Vis, FTIR, and GC instruments and set up a calibration program.

• Provided technical and manufacturing support and testing on teams that developed novel filtration devices and PM2.5 filters.• Project leader and developer of a filtration/extraction device written into a United States Department of Soil Conservation analytical method.• Developed over 100 applications for Whatman HPLC columns. • Assisted customers in developing and/or improving their HPLC and SPE analysis methods.• Evaluated customer complaints and problem troubleshooting for Filtration Devices, HPLC Columns, and Solid Phase Extraction Devices. • Presented two papers at Pittcon on topics related to HPLC and microfiltration, and gave presentations on company products to customers and sales representativesReason for leaving: Department Closed