Richard Napierkowski

QA Regulatory Compliance at JW Nutritional, LLC
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Contact Information
us****@****om
(386) 825-5501
Location
McKinney, Texas, United States Contact Info, US

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Experience

    • Wellness and Fitness Services
    • 1 - 100 Employee
    • QA Regulatory Compliance
      • Nov 2021 - Present

      Allen, Texas, United States Ensure regulatory compliance in accordance with FDA 21 CTR111 guidance. Create, edit and revise Finished product specifications, Certificates of analysis and identify non-conformances, perform investigations, and implement CAP's as necessary. Perform QA review of testing result packets from in-house and third party laboratories. Ensure and implement change controls and updates on finished product specifications as needed.

    • United States
    • Manufacturing
    • QC/QA/Microbiologist
      • Oct 2019 - Nov 2021

      Irving, Texas Receive, prepare, and set-up samples for analysis. Process and maintain client samples at correct temperatures/incubation. Segregate samples by client orientation. Maintain, update and categorize client Certificate of Analysis and Safety Data Sheets, along with coordinating client approvals for incoming and outgoing products. Maintain laboratory conditions including equipment, supplies, quality assurance programs, and accurate records throughout all procedures. Testing of pH, viscosity, weight,… Show more Receive, prepare, and set-up samples for analysis. Process and maintain client samples at correct temperatures/incubation. Segregate samples by client orientation. Maintain, update and categorize client Certificate of Analysis and Safety Data Sheets, along with coordinating client approvals for incoming and outgoing products. Maintain laboratory conditions including equipment, supplies, quality assurance programs, and accurate records throughout all procedures. Testing of pH, viscosity, weight, gram staining, and troubleshooting. Show less

    • United States
    • Biotechnology Research
    • 300 - 400 Employee
    • Laboratory Technician - Logistics
      • May 2015 - Oct 2019

      Grand Prairie, Texas Receive, prepare, and set-up samples for analysis. Process and maintain client samples at correct temperatures. Segregate samples according to FSNS procedure. Assist with shipping of customer supplies including return coolers. Communicate with clients for clarification on orders as needed. Follow assigned series of processes, procedures or techniques in accordance with FSNS policies/procedures and customer requirements. Maintain laboratory conditions including equipment, supplies, quality… Show more Receive, prepare, and set-up samples for analysis. Process and maintain client samples at correct temperatures. Segregate samples according to FSNS procedure. Assist with shipping of customer supplies including return coolers. Communicate with clients for clarification on orders as needed. Follow assigned series of processes, procedures or techniques in accordance with FSNS policies/procedures and customer requirements. Maintain laboratory conditions including equipment, supplies, quality assurance programs, and accurate records throughout all procedures. Cross-training (Microbiology Technician, Pathology Technician, Media Technician ). Following FDA, USDA, APHA, and AOAC guidelines. Show less

Education

  • Bethany College
    Bachelor of Arts (BA), Biology
    2006 - 2011
  • Granbury High School
    High School Diploma
    2002 - 2006

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