Marque Duncan, CQA (ASQ)

Corporate Compliance Auditor at Kedrion Biopharma
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Contact Information
us****@****om
(386) 825-5501
Location
Chapel Hill, North Carolina, United States, US
Skills

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5.0

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Lorri Burch-Hubbard

Marque is a very detail-oriented QA staff member, responsible for reviewing and monitoring detailed corrective action plans.

Kay Crull

Marque is a valued member of the Quality team. He is bright, articulate, and dedicated. He is the "go-to" person for the quality team because of his experience and knowledge in multiple areas of the business.

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Credentials

  • Certified Quality Auditor (CQA)
    ASQ - World Headquarters
    Oct, 2017
    - Nov, 2024

Experience

  • Kedrion Biopharma
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Corporate Compliance Auditor
      • Jan 2019 - Present

      (Formerly Bio Products Laboratory : BPL) Supports and guides the Compliance team by leading the auditing processes with the purpose of evaluating the compliance of internal facilities, corporate functions, and external vendors for compliance with company, industry, and regulatory guidelines and requirements. Operates within the scope of EU Guidance on Good Manufacturing Practices and FDA cGMP 21 Code of Federal Regulations (CFR). {+} Conducts audits of procurement facilities, corporate office, laboratories, distribution centers, storage warehouses, and suppliers to ensure compliance with FDA, EU, CLIA, and cGMP regulations {+} Develops facility, corporate, supplier, and third party compliance checklists {+} Audits records of procurement, processing, research and development, and manufacturing to determine compliance with company SOPs and policies {+} Prepares audit reports based on internal audit findings {+} Evaluates audit responses for adequacy, including root cause analysis, and acceptability for audit closure {+} Conducts follow-up actions for facility, corporate, and supplier audits as warranted Show less

  • American Red Cross
    • United States
    • Non-profit Organizations
    • 700 & Above Employee
    • Quality Assurance Officer
      • Jan 2016 - Jan 2019

      Promoted to oversee the blood collection, manufacturing, and distribution facility as the senior quality assurance professional for the Durham District of the Carolinas and South Carolina Regions of the American Red Cross Biomedical Services. Primary focus is to provide quality and regulatory technical support. The quality assurance (QA) representative integrated into each function of the operations facility providing support, guidance and oversight to the total operation. Works collaboratively with other departments to achieve quality compliance objective and business results. Quality oversight and support for manufacturing, distribution, and patient testing for the Carolinas, South Carolina, Mid-Atlantic, and Appalachian Regions covering the Tri-State Territory of North Carolina, South Carolina, and Virginia. Show less

    • Quality Assurance Senior Associate
      • 2010 - Dec 2015

      Rehired by the organization after previous position was eliminated due to a business driven decision. Review, assess, and monitor records, processes, and systems related to donor and product management in the company's Donor and Client Support Center. Identify quality concerns and provide feedback for process improvement through operations oversight and system review. Consult staff providing interpretation and clarification of standard operating procedures and applicable regulations. Review, assess and approve local written procedures. Show less

  • American Red Cross
    • United States
    • Non-profit Organizations
    • 700 & Above Employee
    • Regional Quality Manager
      • 2002 - 2008

      {+} Manage process improvement functions of the region and staff professionals responsible for this process {+} Manage process of problem investigation, root cause analysis, corrective action plans {+} Identify opportunities for improvement by tracking and trending, quality metrics and data analysis {+} Oversee process improvement initiatives and significant corrective actions {+} Review, assess and monitor records, processes and systems in the blood product manufacturing process {+} Monitor the implementation and effectiveness of corrective actions {+} Identify quality issues, opportunities for standardization and/or process improvements through quality auditing Show less

  • Berean Communities, Inc.
    • Madison, Wisconsin Area
    • Senior Leader
      • 2000 - 2008

      {+} Oversight and direction of the community and management of ministries/programs {+} Community development and consulting community based organizations {+} Directing the business affairs, projects and financial solvency of the organization {+} Developing, training and mentoring apparent and potential leaders in the organization {+} Conducting classes and meetings to include instruction and facilitation {+} Oversight and direction of the community and management of ministries/programs {+} Community development and consulting community based organizations {+} Directing the business affairs, projects and financial solvency of the organization {+} Developing, training and mentoring apparent and potential leaders in the organization {+} Conducting classes and meetings to include instruction and facilitation

  • Volt Services Group
    • Milwaukee, Wisconsin, United States
    • Staffing Specialist | On-Site Coordinator
      • 1997 - 2000

      {+} Hire and supervise temporary employees at Bank One On-Site Location {+} Interview potential candidates and perform background investigations {+} Handle payroll, employee issues, terminations and job orders/assignments {+} Hire and supervise temporary employees at Bank One On-Site Location {+} Interview potential candidates and perform background investigations {+} Handle payroll, employee issues, terminations and job orders/assignments

  • Interstate Blood Bank, Inc.
    • Milwaukee, Wisconsin, United States
    • Plasmapheresis Establishment Director
      • 1992 - 1997

      {+} Direct all center operations and execute them as required {+} Handle accounting, human resources, marketing, payroll and inventory {+} Responsible for regulatory compliance and quality assurance {+} Provide daily, weekly and monthly reports to corporate office and clients {+} Create new policies, programs and forms used company wide {+} Direct all center operations and execute them as required {+} Handle accounting, human resources, marketing, payroll and inventory {+} Responsible for regulatory compliance and quality assurance {+} Provide daily, weekly and monthly reports to corporate office and clients {+} Create new policies, programs and forms used company wide

  • Tennessee Valley Authority
    • United States
    • Utilities
    • 700 & Above Employee
    • Turbine Safety
      • 1990 - 1992

      {+} Inspection of steam turbines during repair and routine maintenance {+} Serve as liaison for the TVA steam/fossil power plants and OSHA {+} Inspection of steam turbines during repair and routine maintenance {+} Serve as liaison for the TVA steam/fossil power plants and OSHA

  • Alpha Therapeutic Corporation
    • Memphis, Tennessee, United States
    • Center Director | Regulatory Compliance Auditor
      • 1986 - 1990

      {+} Direct all operations of the plasma center {+} Increased center’s donor population by 85% {+} Audit the Nashville, Louisville and Lexington centers for Regulatory Compliance {+} Direct all operations of the plasma center {+} Increased center’s donor population by 85% {+} Audit the Nashville, Louisville and Lexington centers for Regulatory Compliance

Education

  • Oakwood University
    Associate, Theology and Religious Education
    1984 - 1986

Community

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