Document Compliance Associate II

• Feb 2022 - Present

• QMS Manager - responsible for quality management system (QMS) in compliance with ISO-9001 and other QMS standards. • System Administrator for PLM Arena and Qualio - responsible for system configuration: setup and maintaining of users, items, change management, routings, routing approvals, training, templates, workflows, etc. • Facilitated mass system clean-up in PLM Arena of outstanding electronic change orders (ECOs) and non-conformances/MRBs • Revamped and spearheaded change control process and implementation process facilitating cross-functional meetings for all effective changes. • Responsible for Non-conformance/MRB process. This includes the review of all open system issues from the field in Salesforce to determine non-conformances and correctly disposition items. • PhenomeX Integration Team - Quality Team Lead for Legacy IsoPlexis. Assisted with the integration of PLM Arena to incorporate both Berkeley Lights & IsoPlexis production workspaces into one instance. Show less

Provider Operations Specialist

• Mar 2020 - Jul 2020

Clinical Services, Provider Operations Specialist ● Responsible for thoroughly reviewing and assessing credentialing process for new providers (Employment History, Work Gap Analysis, Attestations) ● Facilitated and expedited incoming referrals for antibody testing lab orders within numerous systems, while providing analysis for any referrals for antigen testing Clinical Services, Provider Operations Specialist ● Responsible for thoroughly reviewing and assessing credentialing process for new providers (Employment History, Work Gap Analysis, Attestations) ● Facilitated and expedited incoming referrals for antibody testing lab orders within numerous systems, while providing analysis for any referrals for antigen testing

Project Manager

• Jun 2016 - Aug 2019

• Managed numerous Document Management Solutions with varying complexities (Basic Install/Configuration, System Upgrades/Integration, System Migrations) • Responsible for creating and controlling all Professional Services documentation (Project Charter, Project Plan, Discovery Document, Implementation Guide, etc.) • Spearheaded IT Requirements Development during project planning/discovery • Worked with cross-functional team members using project management methodologies to expedite solutions (Dev, QA, Support) • Developed schedules and created baselines to meet project milestones and deadlines • Tracked Resource Management (Forecast/Actuals) to improve time allocation and utilization of resources. Show less

Project and Compliance

• May 2013 - Jun 2016

Project Management Office (PMO) –Project and Compliance May 2013-Present • Worked within Business Units to streamline processes to drive results across multiple platforms • Responsible for maintaining, auditing, and updating the DHF (Design History Files) on the Powered Platform and Access Devices • Maintained Capital Budget for the Powered Platform and created the “Capital Budget Tracker Template” that has been utilized successfully across various platforms for capital budget tracking and forecasting • Facilitated DSRs (Design Stage Reviews) and aided with the retrieval of necessary documents for each stage exit per SOP • Tracked Resource Management (Forecast/Actuals) to improve time allocation and utilization of resources. • Successfully lead Product Transfer Processes from R&D to Plant Show less

Document Control Analyst

• Sep 2011 - Apr 2013

Document Coordinator I Sept 2011-Apr 2013 • Utilized expertise as a Change Analyst to implement Electronic Change Orders/CDPs • Acted as lead coordinator to facilitate and drive projects by identifying road blocks and seeking resolutions • Led effort in development of COAs (Certificates of Analysis) in various countries of Latin America for release of products • Trained cross functional team members on the implementation of Agile 9.3 Show less

Marketing Intern

• May 2005 - Sep 2007