Summary
Overview
Work History
Education
Skills
Timeline
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James Poole

Oakdale,MN

Summary

Effective quality professional bringing proven success in driving continuous improvement initiatives in Quality Engineer roles. Focused and diligent with commitment to fostering corporate mission. Consistently acknowledged for implementing actionable initiative to reduce error rates and optimize company processes. Holds Bachelor's degree in Biology and Chemistry with strong understanding of ISO17025, familiarity with 21CFR Part 820 and ISO13485, with some exposure to 21CFR210/211 and 21CFR Part 58. Laboratory and Medical Device Quality Systems Knowledge.

Overview

18
18
years of professional experience

Work History

Sr Quality Engineer

Medtronic
10.2021 - 10.2023
  • Oversee daily and strategic quality activities within global laboratory services and ensures that laboratory is meeting requirements as set by applicable regulations
  • Test plan and report review and approval
  • Method validation plan and report review and approval
  • Oversight of laboratory Standard Operation Procedures (SOPs), deviations, and SOP/Test Method revisions
  • Management of aberrant result investigations, audit findings, calibration/equipment out of tolerances, and Corrective Actions/Preventive Actions (CAPAs)
  • Lab audit representative for internal and external audits
  • Perform internal audits to audit schedule
  • Familiarity with ISO17025, 21CFR820, and ISO13485 with some exposure to 21CFR210/211 and 21CFR58
  • CAPA Specialist for laboratory services.
  • Member of Analytical Lab Council Quality Working Group
  • Contributed to root cause analysis to determine core reason for failures and errors.
  • Supported quality team members during corrective action updates.
  • Facilitated process improvements to successfully decrease errors.
  • Maintained compliance with industry standards and regulatory compliance during managed projects.

Sr Quality System Specialist

Medtronic
12.2019 - 10.2021
  • Lead Laboratory Quality Projects
  • Investigate laboratory aberrant results, laboratory non-conformances, and equipment out-of-tolerances
  • Review documents and records for compliance to current processes
  • Provide oversight for validation activities and instrument qualifications
  • Maintain laboratory quality processes based on ISO17025
  • CAPA Owner
  • Lead laboratory audit preparation activities and interactions with auditors
  • External Lab audit SME
  • ISO17025 auditor (SME) for internal lab audits
  • Provide guidance for interpretation of regulations and processes
  • Member of Analytical Lab Council Quality Working Group
  • Review updates to incoming inspection procedures
  • Lead project for periodic review of documents
  • Work across functions to make changes to processes that affect laboratory operation.

Quality System Specialist

Medtronic
02.2014 - 12.2019
  • Investigate laboratory aberrant results, laboratory non-conformances, and equipment out-of-tolerances
  • Review documents and records for compliance to current processes
  • Provide oversight for validation activities, instrument qualifications
  • Maintain laboratory quality processes based on ISO17025
  • CAPA Owner
  • Lead laboratory audit preparation activities and interactions with auditors
  • External Lan audit SME
  • Provide guidance for interpretation of regulations and processes
  • Member of Analytical Lab Council Quality Working Group
  • Review updates to incoming inspection procedures
  • Lead project for periodic review of documents
  • Work across functions to make changes to processes that affect laboratory operation.

Chemist

Medtronic
06.2011 - 02.2014
  • Empower2 Administrator
  • LIMS (Laboratory Information Management System) Administrator
  • Prepare buffers and mobile phases as needed for sample analysis
  • Authored Equivalency Plans and Reports
  • Revise and Review Test Methods and Instrument Operating Procedures
  • Review changes to Inspection Procedures
  • Laboratory Investigation Report investigator
  • Coordinator for Outsourced Sample submission and logistics
  • Maintain thorough records and documentation on solution preparation, sample preparation and experiments
  • Maintain laboratory equipment
  • Perform laboratory and product support functions as needed
  • Ensure laboratory and work areas conform to cGMP, SOPs, and Analytical procedures
  • Instrumentation used: HPLC, GC, pH meter, conductivity meter, vacuum oven, shaker bath, color meter, Karl Fisher titrator, FTIR, Refractometer, ICP, SEM, sputter coater.

Contract Chemist

Medtronic
06.2009 - 06.2011
    • Analysis of MCRD (Monolithic Controlled Release Device) drug products and raw materials
    • Sample preparation
    • Sample analysis
    • Analyze raw materials and components intended for use in manufacturing medical devices
    • Empower2 Administrator
    • Prepare buffers and mobile phases as needed for sample analysis
    • Revise Test Methods and Instrument Operating Procedures
    • Maintain thorough records and documentation on solutions, sample preparation and experiments
    • Maintain laboratory equipment and logbooks
    • Perform laboratory and product support functions as needed
    • Ensure laboratory and work areas conform to cGMP, SOPs, and Analytical procedures
    • Instrumentation used: HPLC, GC, pH meter, conductivity meter, vacuum oven, shaker bath, color meter, Karl Fisher titrator, FTIR, Refractometer.

Contract Lab Analyst III

3M
02.2006 - 06.2009
    • Analysis of MDI (Metered Dose Inhaler) drug products
    • Hazardous Waste Coordinator
    • Coordination of hazardous waste disposal generated by experiments
    • Ensure compliance of waste management with GLP and cGMP protocols and regulations
    • Prepare mobile phases and sample diluents as needed for sample preparation and analysis
    • Maintain thorough records and documentation in technical notebook on solutions, sample preparation and experiments
    • Maintain logbooks for laboratory equipment
    • Notebook Peer Review
    • Test and help development of methods
    • Instrumentation used: HPLC, GC, Anderson Cascade Impactor Apparatus, DCU USCA tubes.

Contract QC Analyst

CIMA Labs
05.2005 - 02.2006
    • Analyze raw materials and drug products intended for commercial use
    • Prepare buffers and mobile phases as needed for sample analysis
    • Perform data reduction, review and prepare spreadsheets
    • Maintain thorough records and documentation on solutions, sample preparation and experiments
    • Maintain logbooks for laboratory equipment
    • Perform general laboratory and product-manufacturing support functions as needed
    • Ensure laboratory and work areas conform to cGMP and SOPs
    • Instrumentation used: HPLC, drug product dissolution apparatus, USP tablet disintegration apparatus, TLC, Sieve, Ro-tap, IR dryer, Friabilator, Automated dissolution sampler.

Education

Bachelor of Science in Chemistry -

Viterbo University
LaCrosse, WI
05.2005

Bachelor of Science in Biology -

Viterbo University
LaCrosse, WI
05.2005

Skills

    • ISO 17025 Familiarity and Training
    • ISO 13485 Familiarity
    • 21CFR Part 820 Familiarity
    • 21CFR Part 210/211 exposure
    • 21CFR Part 58 exposure
      • Certified Quality Auditor
      • Root Cause Analysis
      • Quality Processes
      • Technical Writing

Timeline

Sr Quality Engineer

Medtronic
10.2021 - 10.2023

Sr Quality System Specialist

Medtronic
12.2019 - 10.2021

Quality System Specialist

Medtronic
02.2014 - 12.2019

Chemist

Medtronic
06.2011 - 02.2014

Contract Chemist

Medtronic
06.2009 - 06.2011

Contract Lab Analyst III

3M
02.2006 - 06.2009

Contract QC Analyst

CIMA Labs
05.2005 - 02.2006

Bachelor of Science in Chemistry -

Viterbo University

Bachelor of Science in Biology -

Viterbo University

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