Amy Peterson

Experience

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  GSK

  Jan 2000 - Sept 2002

  QC Learning Development Specialist / QC Analytical Chemist

  • Established new laboratory for analytical testing of multi-dose dry powder inhalers (particle size testing); managed test method transfers from UK to US• Designed & implemented Six-Sigma/Lean Manufacturing project; competency-based QC training program; North America • Trained by GSK Black Belt (GSK customized training Advocate Training considered equivalent to Green Belt by GSK)

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  Pfizer

  Sept 2002 - Nov 2010

  Human Performance Model Lead, Sr. QA Specialist II

  In my role as a human performance model lead and Sr. QA specialist II at Pfizer, I received global recognition for reducing deviation and human error rates, implementing the human performance model from North America Commercial Nuclear, and supporting the transition to a new eQMS. I achieved 3 promotions in 8 years and was honored to present on error reduction to QA executive leadership, leading to the global implementation of HPM.

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  Novartis

  Nov 2011 - Jul 2012

  Chief Compliance Officer

  Self-driven, collaborative, strategic technical advisor to senior executive leadership; analyzed multiple product data sources for adverse trends to recommend a new risk-based product portfolio strategy & site metrics (KPI). Ensured effective CAPA closure, monitored & presented adverse trends to leadership- Coordinated remediation strategy between quality, operations, information technology (IT), training. Led eQMS implementation for deviation investigations, defined user requirements for process blueprint, developed procedures & corresponding training for newly designed eQMS.- Developed new communication process of audit observations across OTC division & corporate.- Advised, assisted QA Vice President (VP) & senior quality leadership in developing new site product portfolio to support reopening facility following successful 483 remediation. Show less

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  Effective Quality Systems

  Aug 2012 - May 2020

  Sr. Quality Consultant

  Highly sought leader, successfully exceeding deadlines, remediating GMP QMS, eQMS under challenging conditions; Consent Decree, Warning Letter, FDA Form 483, budget & personnel constraints, drug shortages, biologic, medical device, & compoundingdrug shortages, & ceased operations. Scope inclusive of small to large size organizations across, pharmaceutical, biologic, medical device, & compounding.

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  Natureplex LLC

  May 2020 - May 2021

  Quality Assurance Manager
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  Pfizer

  Jun 2021 - Jan 2025

  As part of the site leadership team, develop and lead site-wide human performance strategy to achieve excellence in execution.- Led team to apply human factoring principles & technical writing standards to MBRs and utilize human error prevention techniques; reduced human error by >70% in gene therapy drug product operations.- Developed and led human error prevention strategy to target batch loss reduction; trained and led team to conduct Human Reliability Analysis with Systematic Human Error Reduction and Prediction Analysis (SHERPA).- Implemented quality near miss program to support formal approach to actively seek and report error provoking conditions.- Provided site-wide human performance metrics to corporate.-Developed error prevention technique toolkit as part of the global human performance team.-Developed and implemented Job Observation Program to asses the performance gap (flawed defenses and error precursors) during task execution. Show less

  • Pfizer Human Performamce Site Lead

    Sept 2022 - Jan 2025

  • New Product Project Manager, Quality

    Jun 2021 - Jun 2023
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  Eli Lilly and Company

  Feb 2025 - now

  Global Sr. Director of Human Performance Reliability & Human Error Prevention