• A passionate and established strong work ethic, exhibited through self-motivation and teamwork. Experienced in Quality Assurance, Quality Systems, Documentation and Training in the Biotech Industry.• Experienced in Document Control and Training Record Management, both manual and electronic systems, management of GxP document workflows from Initiation to Archive. Experienced in establishing Training for GxP users. Document Control support for Inspection readiness, Internal and External Audits, QMS records management, Procedural documents and other controlled GxP documentation activities.
Just Ask
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Just Ask! =)Just Ask Feb 2021 - Present
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Senior Document Control SpecialistSemma Therapeutics Sep 2019 - Feb 2021Streamlined and formalized Document Control workflows and processes within e-doc management system, QT9, and paper based system. Oversaw and managed document workflows, from initiation to publish for use, revision control, to retirement and archive. Maintained electronic and paper training process for all GxP personal and functions. Established and maintained training curriculums, onboarding/off boarding process partnering with HR and IT.
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Senior Document Control SpecialistSage Therapeutics Feb 2018 - Sep 2019Facilitated document workflows, from draft initiation to publication for execution to training. Format, and prepare all GxP procedural documents and forms. Support implementation of eDMS and eLMS, Configuration and Validation of systems, execute Test Scripts. Supported FDA Inspections, Prep war room activities and document requests.Prepare New Hires with Onboarding Training material per departments training curriculums. -
Document Control SpecialistAgios Pharmaceuticals Aug 2015 - Feb 2018Cambridge, MaProcessed and maintained internal procedural documents, along with all gxp documents including training records and vendor management docs. Performed QA New hire Onboarding. Supported eDMS and LMS system validation, testing, and migration activities. Oversaw archive room build out and established archive process. -
Document Control CoordinatorCubist Pharmaceuticals Apr 2013 - Mar 2015Processed and maintained various controlled gxp documents and logbooks. Controlled paper document workflow, from issuance to archive. Maintained paper archive system, tracking and maintaining documents through various databases. -
Document Control CoordinatorShire Pharmaceuticals Aug 2011 - Apr 2013Issued Batch Records and Forms, Logbooks and labels. Reviewed Batch Records and disposition documents. Tracked and maintained databases, filed and organized batch records and other gxp documentation. -
Quality Assurance InternFormatech, Inc. Jun 2006 - May 2009Created training files and assisted in issuance of controlled records. Archived completed documents and assisted in off-site archival activities.
Deepa N. Education Details
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Lexington High School -
Criminal Justice
Frequently Asked Questions about Deepa N.
What company does Deepa N. work for?
Deepa N. works for Just Ask
What is Deepa N.'s role at the current company?
Deepa N.'s current role is Senior Quality Systems Specialist.
What schools did Deepa N. attend?
Deepa N. attended Lexington High School, Umass Boston.
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