Summary
Overview
Work History
Education
Skills
Websites
Community Service
Additional Information - Software Skills
Languages
References
Timeline
Generic

Jose Lizardo

Lynn

Summary

Well-versed Quality Assurance Manager with relevant experience in overseeing the production process, identifying and resolving issues, and ensuring products meet company standards. Strengths include strong communication skills, strategic planning abilities, and comprehensive knowledge of quality control procedures. Previous roles highlighted ability to improve product quality by conducting thorough analysis and implementing effective solutions. Highly skilled in quality control systems management with experience across various manufacturing sectors. Possess deep understanding of compliance standards, process optimization, and risk management strategies. Demonstrated ability to lead teams towards achieving consistent product quality and operational efficiency. Improved system processes and documentation, resulting in enhanced product reliability and customer satisfaction.

Overview

10
10
years of professional experience

Work History

Quality Assurance Manager/Internal Auditor

Takeda Pharmaceuticals
Lexington
01.2024 - Current
  • Collaborated with teams to develop quality assurance protocols and standards that aligned with industry regulations and company standards. Developing and implementing corrective and preventative actions to address nonconformances, trends, and regulatory issues by managing CAPA systems and driving continuous improvements.
  • Aimed to ensure that products and services meet established standards of quality. Maintaining Takeda's quality reputation, process improvements, reducing compliance costs, and ensuring the safety and effectiveness of products.
  • Facilitated CMOs in developing and upholding necessary processes and procedures ensuring DMR compliance
  • Supported documentation efforts for compliance with industry regulations and standards.
  • Provided training for staff and quality assurance practices, ensuring that all employees understand the importance of quality in their roles.
  • Collaborated with other departments, such as production and engineering, to implement quality improvements and resolve quality-related issues.
  • Compiled data on leading initiatives to aim at continuous improvement in processes and product quality, utilizing methodologies like Six Sigma or Lean.
  • Engaged with cross-functional teams to address quality-related issues promptly.
  • Implemented rigorous quality verification processes, validating pharmaceutical and manufacturer materials' compliance with all necessary quality standards ahead of distribution. Maintained accurate records of all tests and inspections performed on the batch.
  • Identified key risk management indicators, mitigations, and risks related to batch release.

Lead Quality Assurance/Regulatory Affairs Specialist III

ZOLL MEDICAL CORPORATION
Chelmsford
01.2023 - 01.2024
  • Executed investigations of product complaints, achieving successful resolutions.
  • Performed final inspections on medical devices, identifying and trending non-compliances.
  • Facilitated continuous improvements and implemented corrective and preventive actions (CAPA).
  • Conducted risk assessments, compiling supporting information and providing recommendations to management.
  • Ensured adherence to internal procedures, ISO standards, and Health Canada requirements in daily operations.
  • Integrated maintenance of ISO 13485:2016 quality system manual into inspection processes.
  • Evaluated regulatory issues, conducting research to develop and implement strategies.
  • Managed communications with regulatory agencies regarding submissions and filing dates.

Quality Assurance Specialist

PROPHARMAGROUP INC
Overland Park
10.2021 - 12.2022
  • Troubleshoot document issues in MS Word, Excel, PowerPoint & Adobe Acrobat Pro
  • Conducted full data entry of adverse events related to a COVID-19 vaccine
  • Partnered in CAPA case corrections during FDA and MHRA audits to ensure regulatory compliance
  • Lead investigation to establish root cause and coordinate failure analysis of non-conforming/ defective material with vendors and outside laboratories
  • Served as Argus Safety System (global safety database) Subject Matter Expert maintaining a workflow of Pharmacovigilance case processing
  • Identified regulatory affairs directions and case referrals according to propharmagroup guidelines
  • Developed client-specifics evolving, training materials for safety database entry manual concentrating on Novavax specific training division
  • Analyzed and recommended actions based priorities risks and benefits for clinical trial documentation
  • Conducted data entry research analyzation for phase II clinical trial
  • Created documentation for phase II clinical trial according to MedDRA dictionary
  • Completed a project on Risk Management Plan (RMP) to identify common features between FDA and EMA RMP
  • Led participants in validation of clinical study reports with time prioritization
  • Prepared and directed written communications for regulatory authorities and safety partners worldwide
  • Reviewed and conducted case assessments accordance with Argus system global pharmacovigilance services
  • Ensured proper product quality complaint documentation followed GMP guidelines according to vendor suggestions

Licensed Certified Nursing Assistant

NORTH SHORE MEDICAL CENTER
Salem
07.2015 - 04.2022
  • Patient Care Associate
  • Infection Control
  • Creating a safe Effective Environment
  • Pain Management
  • Acute/Critical Care
  • Electrocardiogram

Education

Master of Science - Regulatory Affairs, Biopharmaceutical development

Northeastern University
Boston, MA
05-2026

Bachelor of Science - Biology, Medical Science/ Nuclear Medicine

Salem State University
Salem, MA
05.2021

Associates of Science - Health Science

North Shore Community College
Danvers, MA
05.2019

Skills

  • Efficient handling of stressful situations
  • SAP system
  • Oracle printing tool
  • Negotiation skills
  • ISO 13485
  • ISO 14971
  • Competent communication
  • Multi-tasking
  • Excellent computer skills
  • Proficiency in Excel
  • Proficiency in Word
  • Proficiency in PowerPoint
  • Proficiency in Adobe
  • Proficiency in Argus
  • Following GMP guidelines
  • Following GCP guidelines
  • Following GLP guidelines
  • Proficiency in case submissions
  • Bilingual
  • Argus
  • Good oral skills
  • Demonstrated team skills
  • Designing SOP templates
  • Leadership
  • Creativity
  • Effective management
  • Ability to adhere to timelines
  • Exceptional interpersonal skills
  • Public relational skills
  • Strong rapport-building
  • High level of performance
  • Solid management
  • Organization skills
  • Professional attitude
  • Great analytical skills
  • Problem-solving ability
  • Dealing with concrete variables
  • Trackwise system
  • Veeva document lifecycle
  • JDE global ERP system
  • Pride in personal performance
  • Team collaboration
  • Risk management
  • Data analysis
  • Team management
  • PPE compliance
  • Organization and time management

Websites

Community Service

  • SOCRA
  • RAPS
  • MassBio

Additional Information - Software Skills

  • Argus
  • MEDDRA
  • SAP
  • ECTD

Languages

English
Professional
Spanish
Professional
Portuguese
Limited

References

References available upon request.

Timeline

Quality Assurance Manager/Internal Auditor

Takeda Pharmaceuticals
01.2024 - Current

Lead Quality Assurance/Regulatory Affairs Specialist III

ZOLL MEDICAL CORPORATION
01.2023 - 01.2024

Quality Assurance Specialist

PROPHARMAGROUP INC
10.2021 - 12.2022

Licensed Certified Nursing Assistant

NORTH SHORE MEDICAL CENTER
07.2015 - 04.2022

Master of Science - Regulatory Affairs, Biopharmaceutical development

Northeastern University

Bachelor of Science - Biology, Medical Science/ Nuclear Medicine

Salem State University

Associates of Science - Health Science

North Shore Community College

Similar Profiles

CREATE PROFILE
Jose Lizardo