Summary
Overview
Work History
Education
Skills
Timeline
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MADELINE ENCISO

Daly City,CA

Summary

Experienced Technical Writer with a background in Quality Control, offering 3 years of industry expertise. Proficient in GMP practices and Quality Systems. Strong ability to write and edit documentation effectively. Skilled in performing release and stability testing to ensure accuracy and compliance in all work undertaken.

Overview

4
4
years of professional experience

Work History

eQMS Technical Writer and Training Coordinator

Twist Bioscience
06.2024 - Current
  • Support projects to migrate and implement a new electronic quality management system (eQMS) with the goal to centralize and increase efficiency in document management.
  • Convert documents from Confluence into Master Control by utilizing Microsoft Office and Google Workspace while supporting different functional groups with eQMS inquiries.
  • Facilitate the creation, modification, approval, and retirement of controlled documents.
  • Edit and revise documents for clarity, consistency, and compliance with corporate standards.
  • Conducted thorough document reviews to identify inaccuracies, inconsistencies, or areas needing clarification.
  • Implemented feedback mechanisms to continuously improve documentation quality and usability.
  • Edited and proofread technical documents for accuracy and consistency.
  • Trained new employees on documentation protocols and tools to ensure standardization.
  • Managed multiple projects simultaneously while adhering to tight deadlines and project specifications.
  • Managed version control and timely updates of documents through effective project tracking and organization skills.
  • Supported successful audits through meticulous maintenance of accurate records and thorough preparation of required materials.
  • Streamline training management and ensure compliance with regulatory and procedural requirements.
  • Onboard and offboard employees on a routine basis, ensuring training has been assigned according to job position.

Quality Control Stability Operations Technician

FibroGen
03.2022 - 05.2024
  • Supported the scheduling and execution of small molecule and biologics drug product/drug substance stability studies in accordance with FibroGen stability protocols, ICH Guidelines, and Good Manufacturing Practices (GMPs).
  • Managed quality control equipment through SensoScientific Temperature Monitoring System and assisted with the maintenance and repair of equipment.
  • Conducted routine inspections of equipment to ensure compliance with regulatory standards and operational readiness.
  • Performed quality control release testing such as pH Testing, UV Absorbance and UV Scan on biologics drug product and drug substance samples.
  • Completed and reviewed stability documentation in a cGMP compliant manner and assisted in document creation and review via Veeva Document System.
  • Revised SOPs, forms, and approved documents; initiate Deviations, Change Controls, CAPAs, Out-of-Service Notifications and Out-of-Tolerance investigations, as encountered.
  • Conducted thorough root cause analyses for recurring issues, leading to long-term resolutions and minimized system disruptions.
  • Supported stability operations through data management in SLIM, inventory control, and distribution of samples.
  • Conducted annual inventory inspection to track the viability of QC retains and QA reserve samples.
  • Ordered and tracked department supplies; ship stability sample materials/reference standard to external laboratories for testing.
  • Collaborated with cross-functional teams to maintain seamless communication and workflow efficiency.

Quality Control Technician

Lucira Health
08.2021 - 03.2022
  • Conducted quality control lot release testing of COVID-19 and Flu test kits by following test protocols and SOPs in compliance with the quality system.
  • Participated in process development testing of new modifications of COVID-19 and Flu test kits.
  • Perform inspections and audits across all stages of production.
  • Collaborated with Quality Assurance to support root-cause investigations related to nonconformance reports (NCRs) discovered during lot release to prevent reoccurrence.
  • Maintained accurate records on product inspection results and reported findings to the management team.
  • Analyzed data collected during the inspection process to identify trends or patterns related to product defects or malfunctions.
  • Upheld safe operating procedures and maintained lab cleanliness.
  • Trained employees in proper equipment use and product testing procedures.
  • Assisted in training new team members on quality control procedures and best practices.

Education

Bachelor of Arts (BA) - Integrative Biology, Minor in Global Public Health

University of California, Berkeley
Berkeley, California
08.2021

Skills

  • Familiar with Google Workspace, Smartsheets, Asana, Microsoft Office & Adobe
  • Familiar with Veeva, Master Control, & Confluence, SLIM, TrainCaster, Quartzy, ReQlogic & SAP Production
  • SensoScientific Monitoring System
  • Teamwork, Communication & Collaboration
  • Organization & Strong Attention to Detail
  • Flexible and Attentive Learner
  • SOP Writing & Report Preparation for Deviations, NCRs, CAPAs, and Out of Service Notifications
  • Quality Compliance, Operations Monitoring & Electronic Document Management System
  • Documentation management through process approval workflows and adjudicating documents by editing, proofreading, and reformatting
  • Product inspection, equipment calibration, workplace safety
  • Laboratory testing: UV Scan, UV absorbance, pH

Timeline

eQMS Technical Writer and Training Coordinator

Twist Bioscience
06.2024 - Current

Quality Control Stability Operations Technician

FibroGen
03.2022 - 05.2024

Quality Control Technician

Lucira Health
08.2021 - 03.2022

Bachelor of Arts (BA) - Integrative Biology, Minor in Global Public Health

University of California, Berkeley

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MADELINE ENCISO