Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Angelica Lugo

Lugo

Summary

Accomplished Quality Assurance and Administrative professional with progressive experience and proven record of significant, successful contribution in quality management systems, project coordinating, and process improvement. Documented strengths in building and maintaining relationships with a diverse range of stakeholders in dynamic, fast-paced settings.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Owner

Affluent Affairs
10.2024 - Current
  • Plan, coordinate, and execute corporate, social, and virtual events ranging from 10 to 200 attendees, ensuring seamless delivery and alignment with organizational goals.
  • Direct all aspects of event logistics, including venue selection, catering, audiovisual setup, transportation, and on-site coordination.
  • Oversee event timelines, task assignments, and vendor deliverables to ensure projects were completed on schedule and within budget.
  • Maintain strong relationships with vendors, venues, and sponsors to secure favorable terms and foster ongoing partnerships.

Sr. Quality Specialist

Roche Sequencing Solutions
09.2018 - Current
  • Planned and coordinated local and global Q&R team events, optimizing logistics and engagement to support strategic objectives
  • Coordinated international and domestic events, navigating time zone differences, cultural considerations, and compliance requirements.
  • Developed, implemented, and managed a full cycle remote process for internal and external audit inspections including IVDR, ISO 13485:2016, IVDR, MDSAP, MDR and site expansions.
  • Identified and improved Front room and Backroom workflow processes for audit requests enhancing efficiency, minimizing errors overall significantly decreasing wait time for auditors.
  • Managed and coordinated the preparation of bi-annual management review contributions across functional teams including senior management.
  • Supported the Mexican Regulatory Submission for the Non-Invasive Prenatal Testing (NIPT) product by supporting international communication resulting is a successfully approved program in Mexico
  • Coordinated EDMS workflows for new and revised documents and also process monthly periodic reviews.
  • Improved and conducted weekly new employee orientation while managing the Learning Management Systems
  • Supported the LMS migration from Medialab to Cornerstone.
  • Managed the successful move of critical official records, including Design History Files (DHF), Technical Files and GxP records to the new Roche Santa Clara Campus.

Office Manager/ Executive Assistant

VITA WATER
10.2016 - 08.2018
  • Maintained customer/client relations.
  • Forecasted and maintained product inventory.
  • Created and maintained company websites.

Design Engineer

BUYERS ENGINEERING
05.2016 - 10.2016
  • Used proprietary software to design routes of telecommunication for business needs

Regulatory Affairs/ Document Controls Associate

CERUS BIOMEDICAL
09.2015 - 05.2016
  • Identified discrepancies between international and English versions of Standard Operating Procedures (SOPs) for blood transfusions.
  • Controlled documentation that supported regulatory requirements, overseeing the life cycle of documents for completeness, accuracy, and authenticity of documents.

Office Manager/ Executive Assistant

MEANDAL ELECTRIC INC.
06.2011 - 02.2014
  • Maintained City and County permits and business licensing
  • Maintained records management system and recommend changes to records system when appropriate

Education

Associates Transfer - Liberal Arts

Los Medanos Community College
Pittsburg, CA
05.2005

Bachelors Degree Credits - Hospitality Management

California State University EastBay
Hayward, CA
06.2009

Skills

  • Diadoc, MediaLab, Chris LSO, Cornerstone, Google Business Suite, Simple Buy, SAP, MyPLM, ETR eArchive, Excel
  • Strategic planning
  • Business administration
  • Administrative oversight
  • Quality management systems
  • Attention to detail
  • Decision-making
  • Teamwork and collaboration
  • Team oversight
  • Relationship building

Certification

  • ISO 13485 BSI Certified Lead Auditor - BSI (2021)
  • IVDR for Quality and Regulatory - QARAD (2020)
  • MDSAP Implementation - Quality Architect (2020)
  • Advanced Lay Counseling Certified – GHCC (2016)

Timeline

Owner

Affluent Affairs
10.2024 - Current

Sr. Quality Specialist

Roche Sequencing Solutions
09.2018 - Current

Office Manager/ Executive Assistant

VITA WATER
10.2016 - 08.2018

Design Engineer

BUYERS ENGINEERING
05.2016 - 10.2016

Regulatory Affairs/ Document Controls Associate

CERUS BIOMEDICAL
09.2015 - 05.2016

Office Manager/ Executive Assistant

MEANDAL ELECTRIC INC.
06.2011 - 02.2014

Bachelors Degree Credits - Hospitality Management

California State University EastBay

Associates Transfer - Liberal Arts

Los Medanos Community College

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