• Requirements gathering for a global network of 32+ sites containing multiple pharmaceutical business units (Drug Products, API, Soft Gels, Biologics etc.) for the development and implementation of a Laboratory Information Management System (LIMS) to increase lab process efficiencies across the network.• Develop, Lead and Create validation and training strategies and their material documentation.• Work with cross-functional and cross-departmental teams to develop software products that are beneficial to the company and our customers.• Team task management for project schedule adherence.• Maintain system design decisions with team visibility to the decisions.• Process mapping of system and user procedures.• Develop metrics to measure efficiency gains with deployment of global lab software for the individual sites.• Assist in individual site deployment and gap analysis activities.• Feature and system assessments for return on investment.

- Certified computer system validation professional. - Support daily laboratory operations by providing administration and technical support for LIMS, Empower, and all software driven lab equipment.- Lead computer system validation projects for laboratory instruments, software, and spreadsheets.- Responsible for maintaining the integrity of data produced on validated instrumentation.- Responsible for maintaining the validated state of lab instruments.- Performs and defines required data backup, archival, and user maintenance for lab software.- SME resource for global laboratory software projects.

- Functional lead and QC representative for a LIMS v5.1 Implementation project- Work closely with the vendor and in house technical resources to develop a system that meets the business needs with minimal impact to the operation. - Development of site specific User Requirement Specifications, Functional Specifications, Design Specifications, and System Acceptance Test documents for all customization made to the system including data migration, reports, inventory module, SAP module, dashboards, and auto triggers. - Key role in mapping customized legacy data to out-of-the-box core locations and system configuration and security settings.- Develop process work instructions, training documents, and SOPs for site wife business processes affected by the new software. - Validation of the software and all customization. - Development and execution of IQ, OQ, and PQ documents. - Continual education of the technical aspects of the system and how it relates to the functional aspects needed for business processes.

- Perform dissolution testing on finished products including HPLC, UV/VIS and Atomic Absorption.- Management Infrastructure Champion of the Patheon Advantage Initiative responsible for developing and maintaining Key Performance Indicators for the QC Lab, and visual scheduling boards and facilitated the transition to paperless documentation of Empower within the QC Lab-Developed and implemented virtual method logs to showcase best practices for Dissolution testing methods.-Working knowledge of LIMS 3.1 and Empower 2 FR5 systems- Knowledge of USP, FDA, DEA and EPA standards.

-Perform testing on finished products in a GMP environment for production and stability products-Working knowledge of LIMS v3.1 system.-Maintain highly organized documentation.-Knowledge of USP, FDA and EPA standards.

-Prepare tissue and water samples for multiple types of analysis using various extraction techniques/instruments and different cleanup techniques.-Responsible for all moisture analysis and Segmented Flow Analysis within the laboratory-Assist in the research and development of new analytical procedures and the creation of their SOPs-Track and log samples from receipt to disposal by use of FREEZERWORKS database.-Maintain and troubleshoot basic laboratory equipment, perform QC data checks, calibrations, and training of all new employees-Adhere to EPA SOPs and regulations.