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Summary
Motivated and seasoned professional with overall experience ranging from computerized systems implementation to engineering and validation of facilities, utilities, laboratory equipment, computerized systems and manufacturing for the pharmaceutical, medical devices and biotech industries at Puerto Rico and the USA. Provide support to multiple companies as part of their core teams in the Technical Services, Commissioning & Qualification, Automation and Information Technologies (IT) departments, with demonstrated history of producing accurate timely reports and meeting with FDA requirements. Demonstrated ability to thrive in deadline driven environments. Diplomatic and tactful with professionals and non professionals at all levels. Accustomed to handling sensitive, confidential records.
Professional Strengths
*Well- versed with life-cycle methodologies with emphasis on quality assurance and testing practices.
*Ability to read and comprehend business as well as technical requirements.
*Possess excellent communication, analytical, organizational and presentation skills.
*Experience with FDA and ISO regulations.
*Strong knowledge in ISO and OSHA regulation.
*Strong Regulatory Experience (cGMP, OSHA, CFR Part 11).
Qualifications & Skills Summary
Bilingual * Technical Writing * Interpersonal and organizational skills * 30 Hour General Industry OSHA Certification * Business sense * Trained in System Applications and Products (SAP) * Trained in Electronic Document Management System (EDM) * Trained in DocSpace * Professional Presentations * Problem Solving * Ability to work with a high degree of accuracy and recall * Excellent analytical skills
Skills
Guest services
Inventory control procedures
Merchandising expertise
Loss prevention
Cash register operations
Product promotions
Accomplishments
Experience
08/2016 to Present
VALIDATION SPECIALIST, JC AUTOMATIONGrifols Inc. – Murfreesboro, TN,
In charge of the implementation, improvements and strategies of the document preparation and execution processes.
In charge of evaluating the status of the ongoing preparation of and assuring documents are timely completed and delivered.
Developed new SOPs for OSI PI Historian, to provide guidelines for configurations and applications, including visual aids and step by step instructions.
In charge of the integration of stability, environmental monitoring and materials management equipment to the OSI PI - Room Monitoring System.
In charge of the development of Change Requests and Project Plan for the OSI PI - Kaye RF ValProbe Integration for Room Monitoring System.
Development of Life Cycle documentation and Qualification for OSI PI - Kaye RF ValProbe Integration for Room Monitoring System.
In charge of the Validation Activities for the integration of various controlled equipment (stability chambers, HVAC, freezers, refrigerators and incubators) to the OSI PI - Room Monitoring System.
10/2013 to 08/2016
VALIDATION SPECIALISTJanssen Ortho Biologics – City, STATE,
In charge of the implementation, improvements and strategies of the document preparation and execution processes.
Responsible for maintaining and upholding the database of all documents pertinent to the project.
In charge of evaluating the status of the ongoing preparation of and assuring documents are timely completed and delivered.
Identified and determined the milestones regarding the recording and documentation needed in the development and progression of the project.
Follow-up with the reviewers and approvers in the procurement of pending documents in order to assure the advancement of the project.
Developed new SOPs for manufacturing network, to provide guidelines for configurations and applications, including visual aids and step by step instructions.
In charge of the development and approval for the System Development Life Cycle for computer systems, developing documents such as Validation Plans, User Requirements, Functional Specifications Requirements, System Specifications, Traceability Matrixes, Summary Reports, Validation Plan Reports and execution of IQ/OQ/PQ protocols.
04/2013 to 10/2013
VALIDATIONS AND CHANGE CONTROL SUPPORT CONSULTANTJanssen Ortho Pharma – City, STATE,
Developed the computer system validation documentation as part of the validation of the OSI PI system qualification.
Responsible of the system infrastructure qualification (with physical and virtual server's infrastructure) with a server/client based installation.
Development of document control systems to log, track and coordinate documents to address issues between the company and other service providers.
Implementation of processes and tools, providing system reports, maintaining and updating electronic information systems, distributing documents, and ensuring accuracy of all documentation.
In charge of the development and approval for the System Development Life Cycle documentation for computer systems.
01/2012 to 12/2014
VALIDATION AND CHANGE CONTROL SPECIALISTMcNeil Healthcare LLC – City, STATE,
Managing change management process including initiation, development, revision and implementation of change requests, controls and internal GMP documentation regarding reactivation, deactivation and discontinuation processes of identified products, among other internal projects.
Development of document control systems to log, track and coordinate documents to address issues between the company and other service providers.
Follow-up with the reviewers and approvers in the procurement of pending documents in order to assure the advancement of the project.
Handle the tasks of developing, implementing and defining change management strategy.
Perform responsibilities of assessing the change management impact to the organization.
Monitoring and evaluating organization's performance after implementing the change management process.
Archiving and controlling soft and hard-copied controlled documents, department files and resource materials.
Development of documentation and evidence about the enhancements performed as part of the Work Plan remediation activities for the Consent Decree, achieving the approval of the Steps one week before the deadline.
Improvement on the Batch Record review and release system tracker to provide visibility to all McNeil facilities in PR and US, achieving the decrease of time spent in the approval of batch records and release of commercial batches.
Capturing decision trail and supporting information in order to track progress against product delivery promise dates.
Maintaining a shared view of open items, status and action tracking across the virtual production team.
Tracking issues, incidents and deviations as they occur throughout the quality process.
Review specific event information such as events by type, root cause and recurring events to facilitate the release process.
Revising and originating Calibration/Metrology and Preventive Maintenance documents as part of the Regulatory documentation for the validation documents.
Education and Training
Expected in 2013
BS: Chemistry - , GPA: interamerican university of puerto rico - metropolitan campus, san juan, PR Chemistry university of puerto rico - río piedras campus, san juan, pr
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