Summary
Overview
Work History
Education
Skills
Timeline
Generic

Natalia Bermudez

Montgomery

Summary

Quality Assurance & Compliance Professional with experience in CAR-T cell therapy, liquid and solid oral dose manufacturing. Diverse technical background in Investigation/ CAPA/ and Product Complaint System Management. A diligent individual able to establish rapport at all levels and to maintain a work principle that is founded on dedication with the persistence to ensure that all projects are completed to meet established corporate expectations.

Overview

11
11
years of professional experience

Work History

Sr. QA Investigations Lead/ QA Investigations Supervisor

LEGEND BIOTECH
Raritan
04.2022 - 11.2024
  • Managed 9 Quality Leads, providing coaching, mentorship, and conducting mid-year and year-end performance reviews to drive professional growth and accountability
  • Contributed to the implementation of a Rapid Response system for triaging investigations, established the process, identified key personnel, and coordinated triaging coverage across all shifts
  • Supported the transition of the Quality Management System (QMS) from TrackWise to Comet, led the implementation of Risk Priority Number (RPN) scoring for investigations, and established RPN criteria and examples tailored to CAR-T manufacturing to standardize risk assessments and ensure consistent decision-making
  • Trained all investigators and Quality Leads on the implementation of RPN scoring, to ensure the appropriate use of tools such as 5 Whys, and Fishbone Diagram for investigation write-ups to align with the new process
  • Generated custom reports in Comet used site wide to track investigations and CAPAs to ensure visibility into quality metrics
  • Served as the Site Escalation Coordinator for CAR-T manufacturing, partnering with Site Quality and Operations leadership
  • Led escalation meetings with cross-functional stakeholders to align on issue resolution and risk mitigation impacting batch disposition
  • Coordinated follow-up meetings to track action items, monitor progress, and ensure timely batch release
  • Documented escalation outcomes via Veeva to ensure accurate record keeping and support timely batch disposition
  • Developed a site escalation guidance document outlining key criteria for when investigations should be escalated
  • Oversaw the war room for investigations during health authority audits, facilitated documentation retrieval, and ensured timely responses to regulatory inquiries
  • Supported multiple capacity ramp-ups to ensure on-time submissions to FDA

Sr. QA Investigations Lead

LEGEND BIOTECH
Raritan
01.2022 - 01.2023
  • Led daily meetings with Quality Leads to review investigation targets, backlog, and priority investigations to ensure timely completion to meet batch release and regulatory submission deadlines
  • Led the review and approval of investigations, CAPAs, and impact assessments, ensuring timely resolution of investigations
  • Served as Quality Lead on high-visibility records, including Biological Product Deviation Reports (BPDRs) to ensure timely investigation closure and compliance with FDA reporting requirements
  • Supported in the closure of 200+ overdue investigations directly contributing to manufacturing scale-up and reduction of backlog to meet production goals
  • Onboarded and trained new Quality Leads, providing guidance on systems, processes, and day-to-day responsibilities
  • Participated in Health Authority audits and served as Quality Lead for health authority responses, ensuring accurate, compliant, and timely submissions with a quick turnaround to meet regulatory expectations

QA Associate Specialist, Complaints/ QA Specialist, Complaints/ QA Specialist, Systems

PAR PHARMACEUTICAL/ STRIDES PHARMA
Chestnut Ridge
09.2016 - 03.2022
  • Reviewed and approved investigations to ensure compliance with GMP regulations, accurate root cause analysis, proper CAPA implementation, and timely closure to support batch release
  • Facilitated weekly and ad-hoc meetings with area owners to gather updates and address roadblocks that could impact target investigation closure dates
  • Investigated and authored Quality System related investigations
  • Attended daily Gemba meetings, providing real-time updates on open investigations and product complaints to the Site Leadership Team to ensure transparency and timely resolution
  • Generated and presented monthly metrics for investigations and product complaints, providing data analysis and trend identification for Quality Review Board meetings with Senior Leadership
  • Highlighted areas for improvement and prepared monthly Annual Product Review (APR) reports for investigations and product complaints
  • Managed product complaints and commercial CAPAs in TrackWise following site ownership transition, ensuring compliance, documentation accuracy, and continuity
  • Responsible for updating and developing Standard Operating Procedures (SOPs) and work instructions (Wis) to align with the implementation of the new Quality Management System
  • Served as Backroom Lead during FDA inspection, overseeing document retrieval, real-time report generation in TrackWise, and coordinating responses to regulatory inquiries
  • Acted as Product Complaint SME, ensuring timely and accurate support for inspection activities

QA Associate Specialist/ QA Specialist, Complaints

PAR PHARMACEUTICAL/ STRIDES PHARMA
Chestnut Ridge
01.2016 - 01.2019
  • Investigated and tracked product complaints in TrackWise for the New York and Alabama sites, conducting batch record reviews and retain sample inspections
  • Coordinated complaint sample returns, replacements, and reimbursements, while communicating with complainants to gather additional information and ensure thorough resolution
  • Conducted criticality assessments of incoming complaints to identify potential field alerts, ensuring timely escalation to management
  • Performed preliminary investigations for all critical complaints requiring field alert assessment
  • Supported complaint investigations for the California and India sites, collaborating with contract manufacturers and suppliers to ensure timely closure
  • Prepared monthly product complaint metrics, including confirmed defects, lot trends, and on-time closures, for presentation to management during Quality Review Board meetings
  • Prepared APR complaint summary reports for the New York and Alabama sites
  • Assisted in the transition of the Medical Information Contact Center, attending daily meetings with the call center to discuss complaints and ensure proper case routing to the appropriate Quality Sites
  • Performed weekly reconciliations between call center reports and TrackWise to ensure accountability of all Product Quality Complaints (PQC) cases for the New York, Alabama, and India sites

Quality Assurance Complaint Specialist

SONAR PRODUCTS
Carlstadt
05.2015 - 09.2016
  • Managed day-to-day handling, investigation, and documentation of product complaints, ensuring timely and accurate receipt, analysis, and response
  • Organized and maintained an electronic log to assign complaint numbers, track progress, and facilitate timely investigations and closure of open complaints
  • Maintained electronic and hard copy records of all complaint investigations and authored formal investigation letters to communicate findings to customers
  • Reviewed batch records to verify compliance with product release specifications and identify any non-conformances during production
  • Communicated with customers to request additional information as needed and coordinated the return of complaint samples
  • Submitted complaint and retain samples to the laboratory for analysis to support investigation and resolution
  • Monitored product complaint trends and collaborated with relevant teams to determine appropriate corrective and preventive actions (CAPAs) or necessary process changes
  • Evaluated the effectiveness of implemented CAPAs to ensure sustained improvements
  • Supported customer audits by providing relevant data

Quality Control Inspector/ Stability Coordinator

WATER-JEL TECHNOLOGIES
Carlstadt
02.2014 - 05.2015
  • Conducted line clearance and initial inspection of packaging lines, verifying lot numbers and expiration dates for pharmaceutical products and Class II medical devices
  • Ensured finished product quality by performing in-process inspections, including weight checks, seal integrity tests, seal width measurements, and packaging material appearance assessments
  • Ensured the quality of Class II medical devices by performing in-process inspections, including force tests, tension tests, burst tests, and weight checks
  • Conducted conversions, kit assembly, rework, and post-radiation inspections
  • Prepared sample submission forms and coordinated the shipment of finished products to in-house and external laboratories for testing
  • Verified cleaning logbooks to ensure all entries were accurately completed
  • Reviewed batch records, calculated product and packaging material yield, and approved product release for shipment and distribution
  • Pulled samples from stability chambers and submitted them to in-house and external laboratories for testing
  • Verified that lab results met specifications
  • Prepared and submitted stability summary reports for review upon completion of the stability study

Education

BA - Psychology and Science minor

Fairleigh Dickinson University
Teaneck, NJ

Skills

  • Quality management
  • Risk assessment
  • Investigation management
  • Regulatory compliance
  • Data analysis
  • Performance management
  • Root cause analysis
  • Process improvement
  • Quality metrics
  • Escalation coordination
  • Complaint resolution
  • Employee training
  • Team collaboration

Timeline

Sr. QA Investigations Lead/ QA Investigations Supervisor

LEGEND BIOTECH
04.2022 - 11.2024

Sr. QA Investigations Lead

LEGEND BIOTECH
01.2022 - 01.2023

QA Associate Specialist, Complaints/ QA Specialist, Complaints/ QA Specialist, Systems

PAR PHARMACEUTICAL/ STRIDES PHARMA
09.2016 - 03.2022

QA Associate Specialist/ QA Specialist, Complaints

PAR PHARMACEUTICAL/ STRIDES PHARMA
01.2016 - 01.2019

Quality Assurance Complaint Specialist

SONAR PRODUCTS
05.2015 - 09.2016

Quality Control Inspector/ Stability Coordinator

WATER-JEL TECHNOLOGIES
02.2014 - 05.2015

BA - Psychology and Science minor

Fairleigh Dickinson University

Similar Profiles

CREATE PROFILE
Natalia Bermudez