Elisa Carbonell
Sr. Validation Engineer at ValSource Inc.- Claim this Profile
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Topline Score
Bio
David Betts
Elisa is an excellent colleague, and an asset to the organization. She is helpful and practical, two qualities important to her position in QA. She is diligent in her pursuit of compliance. Elisa's sense of humor makes her a joy to work with.
Katherine Lake
Elisa is fabulous to work with. She is a quality professional with extensive Quality System experience and knowledge. She has great communication skills and is able to interact with all departments and assist others. Her great personality, honesty and positive attitude make working with her a great pleasure. I highly recommend Elisa and she would be an asset to any company.
David Betts
Elisa is an excellent colleague, and an asset to the organization. She is helpful and practical, two qualities important to her position in QA. She is diligent in her pursuit of compliance. Elisa's sense of humor makes her a joy to work with.
Katherine Lake
Elisa is fabulous to work with. She is a quality professional with extensive Quality System experience and knowledge. She has great communication skills and is able to interact with all departments and assist others. Her great personality, honesty and positive attitude make working with her a great pleasure. I highly recommend Elisa and she would be an asset to any company.
David Betts
Elisa is an excellent colleague, and an asset to the organization. She is helpful and practical, two qualities important to her position in QA. She is diligent in her pursuit of compliance. Elisa's sense of humor makes her a joy to work with.
Katherine Lake
Elisa is fabulous to work with. She is a quality professional with extensive Quality System experience and knowledge. She has great communication skills and is able to interact with all departments and assist others. Her great personality, honesty and positive attitude make working with her a great pleasure. I highly recommend Elisa and she would be an asset to any company.
David Betts
Elisa is an excellent colleague, and an asset to the organization. She is helpful and practical, two qualities important to her position in QA. She is diligent in her pursuit of compliance. Elisa's sense of humor makes her a joy to work with.
Katherine Lake
Elisa is fabulous to work with. She is a quality professional with extensive Quality System experience and knowledge. She has great communication skills and is able to interact with all departments and assist others. Her great personality, honesty and positive attitude make working with her a great pleasure. I highly recommend Elisa and she would be an asset to any company.
Credentials
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Labware Certified Admin
LabWare
Experience
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ValSource Inc.
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Sr. Validation Engineer
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Apr 2022 - Present
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Bristol Myers Squibb
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Pr. Scientist, Sr. Manager Computer Systems Maintenance
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Nov 2019 - Sep 2022
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Principal Scientist, Computer Systems Maintenance
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Nov 2014 - Nov 2019
Maintain all Computerized Systems/Software for the Phoenix Mfg. site. Administrator/Site Technical Support for LabWare LIMS 7. Implement/Validate new Quality Systems mainly for the QC Labs. Manage projects from vendor selection thru implementation, including writing Validation documents (e.g., URS, OQ/PQ protocols, test scripts, etc.). Write/revise SOPs, initiate Change Controls, Deviations, etc. Always on the lookout for Continuous Improvement opportunities and I am a great troubleshooter.
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Dendreon
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United States
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Biotechnology Research
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300 - 400 Employee
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Sr. QA Associate
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Jul 2010 - Oct 2014
Maintain Quality Systems, Deviations/CAPA, Change Control, Document Control, Batch Record activities (i.e. Issuance, Review, Closure), Quality on-the-floor, etc. • Performs GMP internal audits and monitors compliance. • Performs batch records issuance, verification and review. • Reviews and analyzes data and documentation. • Processes deviations and non-conformances. • Writes documents, standard operating procedures and reports. • Participate in thorough investigations into product failures using standard industry investigation tools (e.g., Root Cause Analysis, DMAIC, 5 Whys). • Change Control management • Product Complaints • Biological Product Deviation Reports • Perform trending of Quality metrics . • Participate in Quality-on-the-Floor by developing strong working relationships with partners in Operations and providing real-time input to developing issues. Show less
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Pinpoint IT Services
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IT Services and IT Consulting
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1 - 100 Employee
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LIMS Administrator
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May 2008 - Jul 2010
Configure, validate and maintain LabWare LIMS system for a tobacco manufacturer. Configure, validate and maintain LabWare LIMS system for a tobacco manufacturer.
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VelQuest Corporation
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United States
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Software Development
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1 - 100 Employee
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Application Engineer
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Nov 2007 - May 2008
Convert paper methods using unique VelQuest MethodBuilder coding application to electronic format for use in SmartLab (an electronic notebook system). Convert paper methods using unique VelQuest MethodBuilder coding application to electronic format for use in SmartLab (an electronic notebook system).
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Amgen
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United States
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Biotechnology Research
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700 & Above Employee
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Sr. QAL Associate
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Dec 2005 - 2007
In this position I served as the Site LIMS Administrator on a SampleManager LIMS application. I am the site lead for all templating activities. I provide input to Business Analysts, Business Leads and Development on implementation options and solutions. Create and manage Enterprise Document Management (EDM) teams for templating and support teams Liaison between end users and corporate project team and developers Coordinate end user support with BA and Corporate Support team members Manage LIMS templating change controls and produce monthly metrics measuring performance Provide LIMS business impact assessments on change controls for manufacturing, analytical methods, specifications, LIMS report and configuration changes Write SQL queries to extract data for investigations, trending and other business needs Responsible for user account creation and maintenance Show less
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Purdue Pharma L.P.
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Sr. QA Specialist
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2002 - 2005
Administrator of QUMAS edoc compliance system. Validation/Implementation included IQ/OQ/PQ, writing test scripts, execution and review, training users, etc. Administrator of QUMAS edoc compliance system. Validation/Implementation included IQ/OQ/PQ, writing test scripts, execution and review, training users, etc.
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Sr Quality Specialist
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2002 - 2005
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Emisphere Technologies
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Sr. Quality Specialist
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2001 - 2002
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URL Pharma, Inc.
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Technical Writer
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May 1998 - Nov 2001
Implemented electronic document managament system. Responsible for creating, modifying, maintaing all documents related to analytical methods and specifications. Writing SOPs. Implemented electronic document managament system. Responsible for creating, modifying, maintaing all documents related to analytical methods and specifications. Writing SOPs.
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Chemist
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1996 - 1998
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