Business Analyst Resume

TECHNICAL EXPERIENCE:

Business Analyst

Confidential

Responsibilities:

Provided Record, Person and Selection Value import services for a new process that measured the efficacy of vendor contracts that provided product and packaging inventory.
configured multiple Parent/Child Custom processes tracking Blood work services for Customers in 360 Sites. This configuration leveraged Divisions within Trackwise and gave the Bio Tech Company the information security it requested across multiple sites.
Developed UAT scripts in HP’s Quality Center to validate the configuration to the company’s SOPs and Functional requirements.
Developed Single and Multi Reports to provide management the metrics necessary for improved delivery of service.
Developed multiple Single and Multi Reports into a highly regulated pharmaceutical environment using crystal reports and utilized shared variables to create the sub reports necessary to export into excel.
Configured in Trackwise 8the family of manufacturing processes that allowed management to audit the output of semi - conductor platforms, while tracking the amount of product defects and their resolution.
Consulted on the design, development, and integration of the eMDR business process and mapping tool into the current Complaint process. Made process recommendations, best practiced in the Medical Device industry in keeping with FDA Compliance and TrackWise 21 CFR Part 11 functionality.
Consulted on the Non Conformance business process and created an assessment and recommendation report that emphasized the industries best practices and 21 CFR Part 11 Compliance.
Created test scripts to validate the implemented changes into the current Non Conformance business process and modified the Computer Based Training modules that were affected by those process changes.

Confidential

Business System Analyst / Application Engineer

Responsibilities:

Successfully implemented various 21 CFR Part 11 compliant TrackWise processes including, but not limited to, Deviations, Complaints, CAPAs, Change Control, Audits and Investigations within the pharmaceutical and biotech industries.
Created UAT Test scripts in HP’s Quality Center to validate configuration and adherence to SOP and FDA’s 21CFR Part 11 compliance.
Business Process development with organizations SME’s to identify and develop efficient and industry best practiced business processes to allow configuration into the TrackWise QMS system. This phase would also identify and include the inherent automation and notification capabilities of TrackWise.
Developed insightful Crystal reporting solutions for clients, based upon their processes, using Crystal Reports.
Responsible for training end-users and administrators in TrackWise configured processes, using QMS best practices.
Typically worked with the clients SME’s to develop the User Requirements Specification(URS) and to formalize that document into HP’s Quality Center
Create customized workflows using QMS business processes to aid in the configuration of TrackWise, versions 6, 7 and 8 Software.
Created CBT training lesson modules, for internal instructional courses of the clients configured TrackWise processes, using Oracle’s Productivity Kit.
Executed IQ, OQ and PQ validation scripts and authored the documentation for those processes configured within the Trackwise application.

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