An experienced senior level Scientist in the pharmaceutical industry with expertise in technical laboratory methodology, testing raw materials, stability samples, method transfer, in-process, process and packaging validation projects, complaints and finished dosages forms. * Skilled in operating and Troubleshooting of HPLC, LC - MS, GC, GC - MS, ICP, UV/VIS, IR, NMR, SOTAX, Viscosity, Dissolutions-automated and manual, Particle size analysis. * Review Test Methods, departmental SOP's and Protocols for accuracy. Reviewed standard inspection plans for analytical results according to Test Monograph version changes. * Ensure that sampling, testing, and documentation of incoming materials is performed in compliance with established, approved written procedures * Managed validation projects, designed validation quality plan (QP), reviewed protocols, SOP's, performed analyses, processed data, audited data generated by others using LIMS/SAP-QM, reported results into LIMS for approval. * A "right first time" attitude that embraces a quality mindset and culture. * Good oral and written communication and leadership skills. * Proficient in technical writing, data trend analysis, Chromatography, Dissolution, LIMS. * Experienced in federal and state regulations: FDA/ ICH/DEA/EPA/USP/EP/BP/cGMP/GLP/ OSHA /CAPA and Six-Sigma policies. * Supported Analytical Method Development for Sterile Suspensions. Contributed to the development and implementation of new technology, specially improving ELN reporting. * Supported drug product Formulation and Process Development including characterization, identification of In-process materials and Finished product. * Strong validation engineering experience with Laboratory Information Management Systems (LIMS) and Integration with equipment's (HPLC, GC, FTIR, Spectrophotometer, Viscosity, pH meter), Electronic Document Management System (EDMS). * Tested and validated process validation samples and special projects such as bulk hold time study, re-validation activities as assigned in support of product transfer from one site to another utilizing applicable analytical procedures. * Assure that all lab instruments are audited in a timely manner and in compliance with appropriate regulations. Assure that software is adequately documented and validated. Instrumentation Expertise: * Skilled in operating and Troubleshooting of HPLC, LC - MS, GC, GC - MS, ICP, DSC, UV/VIS, AA, IR, NMR, Dissolutions - automated and manual, Viscosity, Particle size analysis.

Highlights:

Companies I like:

1965

• EP
• Inventory
• Software
• High Performance Liquid Chromatography (HPLC)
• Test
• Quality
• Compliance
• Troubleshooting
• Audit
• Complaints