Katie Atworth
Lake Stevens,WA
Summary
Quality Systems Specialist with considerable experience in optimizing quality management systems and ensuring regulatory compliance. Adept at driving continuous improvement through collaborative team efforts and adaptable to evolving business needs. Core skills include system auditing, root cause analysis and investigation oversight, and risk management. Known for reliability, strong communication, and results-driven mindset.
Overview
12
12
years of professional experience
Work History
Quality Systems Specialist III
Bio-Rad Laboratories, Inc
10.2017 - Current
- Participates in regulatory audits and inspections to demonstrate compliance with applicable standards and regulations. Includes GMED, FDA, customer, and internal audits.
- Collaborate cross-functionally with applicable departments including the provision of root cause analysis guidance to establish effective corrective action plans in response to audit recommendations or nonconformances.
- Coordinator for materials' review board to identify, investigate, and resolve quality issues pertaining to suppliers and the receipt, inspection, and management of raw materials utilized in production processes. Includes tracking quality issues with external customers, suppliers, and internal plant operations.
- Participated in the creation of a Risk Management Program and Post-Market Surveillance Program in adherence to applicable standards including ISO 14971:2018 and IVDR.
- Oversees all Risk Management documentation maintenance including pFMEA and risk file revisions as outputs of CAPA, nonconformance investigations, Change Control, customer complaints, post-market surveillance, etc. Chair of quarterly Risk Management Board meetings wherein pertinent risk related topics are discussed.
- Participates in Quality Plan development and implementation including working interdepartmentally to resolve complex production-related quality issues through workshops and procedural analysis and assessment for improvement opportunities.
- Supports CAPA activities through all phases, with emphasis on risk management
- Performs standard quality system specialist job duties including data mining, trending, and analysis for executive leadership; production batch record review following GxP and Data Integrity requirements; final release of catalog kits to customers, from lot release protocol review to performance of final usage decision.
Research Materials Management Coordinator
Seattle Children's Research Institute
03.2014 - 10.2017
- Responsible for ordering, receiving, tracking, and managing of raw material inventory to be used in GMP/sterile suite environments.
- Resolved vendor and manufacturer-related conflicts and documented all Root Cause Analyses and CAPA reports as necessary per material investigations.
- Optimized the inventory system by implementing "red/green" bin system to provide visual inventory triggers for purchasing frequency.
- Assisted in the research for and acquisition of a LIMS system prototype to test as a tool for inventory management.
Education
Bachelor of Science - General Biology
University of Washington
Seattle, WA06.2013
Skills
- Quality management systems; tracking, maintaining quality metrics
- Document Control skills
- Investigation management through Quality Planning, quality review boards, CAPA
- ISO standards including 14971:2019, ISO 13485, and IVDR for European certification
- Risk Management, Post-Market Surveillance, Usability in in-vitro Medical Devices
- Proficient in Veeva, SAP, Airtable, Sharepoint, Microsoft Office,
Timeline
Quality Systems Specialist III
Bio-Rad Laboratories, Inc
10.2017 - Current
Research Materials Management Coordinator
Seattle Children's Research Institute
03.2014 - 10.2017
Bachelor of Science - General Biology
University of Washington