Summary
Overview
Work History
Education
Skills
Awards
Certification
Timeline
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Elizabeth Stout

Hutchinson,KS

Summary

Strong planner with experience in project management and problem solving. Readily adapts to change, works independently, and consistently exceeds expectations. Able to juggle multiple priorities and meet tight deadlines without compromising quality.

Overview

12
12
years of professional experience
1
1
Certification

Work History

QA Documentation Project Lead

Pfizer
09.2023 - Current


  • Investigations, CAPAs, and Effectiveness
  • Checks Assist in Regulatory Audit as SME, Document processor, and Lead
  • Process SOP and additional GMP document in the PDOCS system
  • Manage Department Projects by using metrics
  • Developed and implemented project plans and budgets to ensure successful execution.
  • Tracked project and team member performance closely to quickly intervene in mistakes or delays.
  • Reported regularly to managers on project budget, progress, and technical problems.
  • Facilitated clear communication between internal departments, ensuring all parties remained aligned on goals throughout the duration of each project.
  • Produced quality standards, checklists, report templates, and processes.
  • Met with manager weekly to provide detailed project report and milestone updates.

Senior Data Analyst

Pfizer
11.2018 - 09.2023
  • Compile Annual Product Record Review sections for CQ, BQ, and Stability Labs Address trending issues and work with leadership to resolve
  • Draft memos to provide necessary information on findings and justification to release product
  • Process SOPs and additional GMP documentation in the PDOCS system
  • Responsible for Change Requests and Action Items for the labs
  • Managed the document process to ensure all documents were effective by required timeline for the IQ/BR Split Project Assisted site in IR Blitz to ensure the site was compliant and prepared for Regulatory Inspections
  • Qualified Trainer
  • Assist in Backroom activities for Regulatory audits as Document Processor and Coordinator
  • Assisted documentation team with SAP updates to SOPs
  • Manage calibrations in EAMS for the Chemical Quality Lab
  • Performed root-cause analysis on data-related system problems to recommend or execute corrective action.
  • Created and automated data visualizations to present insights and tell compelling stories.

M4/M20 Attendant

Pfizer
05.2017 - 11.2018
  • Aseptic Trained
  • Visual Inspection trained
  • Processed Batch Records according to cGMP requirements
  • Back Up SPO Certified Trainer

Payroll Development

Kroger
10.2015 - 04.2017
  • Payroll Development Provided customer service to the Divisions and Associates
  • Researched and assessed roadblocks for accounting errors and issues
  • Analyzed financial data for the Divisions and forecasted spending
  • Processed benefits and researched overage and shortages
  • Developed application to improve processes
  • Project Management Helped reduce cost for Divisions
  • Accounting Worked with Auditing firms for both state and federal.

UPHW Contract Admin

Kroger Accounting Services
07.2013 - 10.2015
  • Provided customer service to the Divisions and Associates Processed Health and Welfare and Pension for Union Associates Trained and developed incoming employees
  • Worked with auditing firms for the union associates
  • Processed Leave of Absences
  • Project Management Accounting

Assistant Manager HR

The Fresh Market
04.2012 - 07.2013
  • Provided training to all Associates
  • Developed in-store training program
  • Written and verbal communication with all Associates Worked with customers to ensure complete satisfaction
  • Budget Planning and allocating to all the Departments


Education

Bachelor of Science in Business Administration -

Everest University
Orlando, FL
10.2014

Skills

  • Budget Control
  • Project Management
  • Performance monitoring
  • Phone and Email Etiquette
  • Employee Coaching
  • Critical design review
  • Customer Relationship Management
  • Root Cause Analysis
  • Documentation And Reporting
  • Team motivation
  • Team Leadership
  • Quality Assurance

Awards

  • W.E. Upjohn Award, IQ/BR Split Project: Awarded for going above and beyond expected performance and demonstrating Pfizer Values for Excellence and Courage.
  • W.E. Upjohn Award, EM Document Updates: During the shutdown of 2020 for the McPherson site, there was a need to update multiple documents and create multiple forms to complete critical shutdown action items. Liz willingly volunteered to help a group that she is not directly tied to in job responsibilities and created, routed, and tracked multiple document updates, and forms in a very short period. With her help the group was able to meet the deadlines of these action items. Liz demonstrated the value of excellence by ensuring that all associated PDOC documents were 'right first time', which allowed for quick document turnover for the group. Liz also demonstrated the value of joy by being willing to help and having a great personality/outlook while performing the activities.
  • Pfizer Value of Joy, Awarded for support on Vancomycin 1.5 g program.
  • Pfizer Value of Excellence, Awarded for always thoroughly completing the TRA process, it makes is easier to complete and finish.
  • Pfizer Value of Excellence and Joy, Liz aided in the transferring of the remaining Thermo LIMS Stability Studies into gLIMS. She pulled reports from Thermo for all the remaining time points and studies in the Thermo system, making sure all data fields were available for transfer. She did extra research into Thermo projects to make sure all studies were found for transfer. With her efforts to support this project, we were able to meet all timelines established for this project. Liz demonstrated excellence and joy during the transfer of the Thermo LIMS Stability Studies to gLIMS. She made sure we had all the data needed for transfer and did so while managing her current workload to ensure a successful project.
  • Pfizer Value of Excellence, Thank you to all who aided several investigations, affecting multiple departments. Your willingness to provide support and information lead to the successful identification of the root cause(s). Your actions lead to effective resolutions that were implemented in a timely manner, allowing us to maintain our compliance and confirm our commitment to quality for our patients!
  • Pfizer Value of Excellence, Kerry and Liz worked together to create and verify a data table in support of a Retacrit sub-visible particulate matter data evaluation. Not only did they gather and verify the data, they completed it 10 days before the projected timeline. Their focus on what matters and pride in their work was clearly evident during the project. Thank you, ladies, for your time and excellent work.
  • Pfizer Value of Excellence, Liz went above and beyond her job responsibilities and helped me route impacted documents for the gLIMSV8 upgrade. She finalized all the documents and made sure all were effective dated by the time needed for the system upgrade. Liz demonstrated the Pfizer value of Excellence. She was focused on helping to make sure that all SOPs were in order and effective dated by the time the system upgraded which allows for all the laboratories to be working from the most current documents for the system upgrade.

Certification

  • Project Management Master Certificate , Pfizer - WSU
  • Informational Mapping Certified, Pfizer

Timeline

QA Documentation Project Lead

Pfizer
09.2023 - Current

Senior Data Analyst

Pfizer
11.2018 - 09.2023

M4/M20 Attendant

Pfizer
05.2017 - 11.2018

Payroll Development

Kroger
10.2015 - 04.2017

UPHW Contract Admin

Kroger Accounting Services
07.2013 - 10.2015

Assistant Manager HR

The Fresh Market
04.2012 - 07.2013

Bachelor of Science in Business Administration -

Everest University
Elizabeth Stout