Chrislyn Dangca
IT Systems Analyst at Dermira, Inc.- Claim this Profile
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Bio
Credentials
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ComplianceWire Certificate of Completion Training - Basic and Advanced Administrator
UL Compliance to PerformanceFeb, 2017- Nov, 2024
Experience
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Dermira, Inc.
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Biotechnology
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1 - 100 Employee
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IT Systems Analyst
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May 2019 - Present
• Facilitating all data and documentation transition upon acquisition of a product • Provide IT Project Management on related business systems projects for Clinical, Regulatory Affairs, Finance, Quality and Technical Operations. • Facilitating requirements gathering, analysis sessions with business partners, coordinate change control activities, configuring and supporting enhancement. Prioritize initiatives based on business needs and requirements. • Supports in the implementation and… Show more • Facilitating all data and documentation transition upon acquisition of a product • Provide IT Project Management on related business systems projects for Clinical, Regulatory Affairs, Finance, Quality and Technical Operations. • Facilitating requirements gathering, analysis sessions with business partners, coordinate change control activities, configuring and supporting enhancement. Prioritize initiatives based on business needs and requirements. • Supports in the implementation and validation activities of Adobe Sign and Veeva Vault eQMS. Improve upon IT’s GxP and Computer System Validation procedures, tools and templates. • Created and executed a transition plan from Quality to IT and ramped up management the ERP systems and manages the Finance System portfolio • Coordinate change control activities for various Non-GXP, GxP and SOX regulated systems. Execute changes when needed. Performing periodic review of systems.
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Quality Assurance Document Control Specialist
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Mar 2018 - Jul 2019
• Gathering requirements from multiple Business partners regarding expanding the utilization of Veeva Vault QualityDocs for additional department. Indexing and Archival of paper process. • Supported in the implementation and validation activities of LMS (ComplianceWire) with the integration to EDMS (Veeva Vault QualityDocs). Coached and assisted with Dermira’s GxP training program including the distribution of training records, filing of completed records, oversight of training compliance… Show more • Gathering requirements from multiple Business partners regarding expanding the utilization of Veeva Vault QualityDocs for additional department. Indexing and Archival of paper process. • Supported in the implementation and validation activities of LMS (ComplianceWire) with the integration to EDMS (Veeva Vault QualityDocs). Coached and assisted with Dermira’s GxP training program including the distribution of training records, filing of completed records, oversight of training compliance, and periodic auditing of training records. • Established and executed a process for documentation preparation for migration to Dermira EDMS including external documents from CROs and CMOs along with archival of hard copies • Maintained GxP related quality system master and historical SOPs including routing of new and revised procedures according to established timelines, editing of documents based on stakeholder feedback, management of effective and obsolete records.
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Ardelyx, Inc.
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United States
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Biotechnology Research
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100 - 200 Employee
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Quality Assurance Document Control Specialist
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Aug 2016 - Mar 2018
• Supports in the implementation and validation activities of LMS (ComplianceWire) with the integration to EDMS (Veeva Vault QualityDocs) • Executes and reviews User Acceptance Testing (UAT) Scripts, Performance Qualification (PQ), User Requirement Specification (URS), Application Configuration Specification (ACS), Connector Configuration Settings • Supports and provides training to cross functional teams both internal and external on the use of EDMS, LMS, change control procedure and… Show more • Supports in the implementation and validation activities of LMS (ComplianceWire) with the integration to EDMS (Veeva Vault QualityDocs) • Executes and reviews User Acceptance Testing (UAT) Scripts, Performance Qualification (PQ), User Requirement Specification (URS), Application Configuration Specification (ACS), Connector Configuration Settings • Supports and provides training to cross functional teams both internal and external on the use of EDMS, LMS, change control procedure and other quality processes as well as update and maintain employee training records • Reviews submitted controlled records and controlled documents to ensure the use of correct templates, classification, training and quality requirements prior to uploading in EDMS. • Develops Work Instructions for Learning Managements Systems and supports with the creation and review of SOPs to meet Ardelyx’s requirements • Performs QC and review of EOP2 (End of Phase 2) Type C FDA Briefing Documents • Coordinate the translation of controlled records with approved vendors • Supports in the management of approved vendors list and audit schedules • Supports in establishing project quality goals, metrics, and lot genealogy • Supports with batch record review • Performs other related duties as needed Show less • Supports in the implementation and validation activities of LMS (ComplianceWire) with the integration to EDMS (Veeva Vault QualityDocs) • Executes and reviews User Acceptance Testing (UAT) Scripts, Performance Qualification (PQ), User Requirement Specification (URS), Application Configuration Specification (ACS), Connector Configuration Settings • Supports and provides training to cross functional teams both internal and external on the use of EDMS, LMS, change control procedure and… Show more • Supports in the implementation and validation activities of LMS (ComplianceWire) with the integration to EDMS (Veeva Vault QualityDocs) • Executes and reviews User Acceptance Testing (UAT) Scripts, Performance Qualification (PQ), User Requirement Specification (URS), Application Configuration Specification (ACS), Connector Configuration Settings • Supports and provides training to cross functional teams both internal and external on the use of EDMS, LMS, change control procedure and other quality processes as well as update and maintain employee training records • Reviews submitted controlled records and controlled documents to ensure the use of correct templates, classification, training and quality requirements prior to uploading in EDMS. • Develops Work Instructions for Learning Managements Systems and supports with the creation and review of SOPs to meet Ardelyx’s requirements • Performs QC and review of EOP2 (End of Phase 2) Type C FDA Briefing Documents • Coordinate the translation of controlled records with approved vendors • Supports in the management of approved vendors list and audit schedules • Supports in establishing project quality goals, metrics, and lot genealogy • Supports with batch record review • Performs other related duties as needed Show less
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Humane Society Silicon Valley
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United States
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Non-profit Organizations
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1 - 100 Employee
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Volunteer Surgical Assistant
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Sep 2012 - Sep 2016
• Administered medication and prepared medical kits • Measured animal vital signs • Assisted technicians in preparation of animals for surgery • Administered medication and prepared medical kits • Measured animal vital signs • Assisted technicians in preparation of animals for surgery
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Milpitas Optometric Group
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Milpitas, CA
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Optical Technician and Front Desk Receptionist
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Jul 2012 - Jul 2016
• Performed pretesting on patients using optical instruments: I-Script, Optomap, Cannon OCT, Weiss • Evaluated patients’ prescriptions in ensure their visual requirements are fulfilled • Assisted office staff in customer service • Performed pretesting on patients using optical instruments: I-Script, Optomap, Cannon OCT, Weiss • Evaluated patients’ prescriptions in ensure their visual requirements are fulfilled • Assisted office staff in customer service
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Assistant Accounts Payable
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May 2008 - Dec 2009
• Registered accounts payable invoices and maintained vendor accounts into accounting software • Gathered appropriate signature(s) for check signing • Assisted with entering journal entries • Registered accounts payable invoices and maintained vendor accounts into accounting software • Gathered appropriate signature(s) for check signing • Assisted with entering journal entries
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Education
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2009 - 2012
UCSD
Bachelor of Science (BS), Biology, General -
2005 - 2009
Mission College
Associate of Science (A.S.), Biology/Biological Sciences, General
Community
