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Carolyn Bowers is a seasoned quality professional with 20+ years of experience in managing quality systems, implementing process improvements, and leading cross-functional teams. She holds an MBA from Rensselaer Polytechnic Institute and a BS in Environmental Science (Toxicology) from the University of Massachusetts, Amherst. Carolyn is certified as a CMQ/OE, Six Sigma Green Belt, Six Sigma Lean & DFSS, and CQA, and has worked in various industries, including pharmaceuticals, automotive, and consumer goods.

Credentials

  • CMQ/OE - Certified Manager of Quality/Organizational Excellence
    ASQ
    May, 2015
    - Apr, 2026
  • Six Sigma Green Belt Certification
    -
    Feb, 2013
    - Apr, 2026
  • Six Sigma Lean & DFSS Certification
    -
    Feb, 2013
    - Apr, 2026
  • CQA - Quality Auditing Certification
    ASQ
    Oct, 2012
    - Apr, 2026
  • Medical First Responder
    American Red Cross
    Mar, 2012
    - Apr, 2026

Experience

  • Iconix Brand Group
    • Morristown, Tennessee, United States
    • Quality Supervisor
      • Jul 2021 - Present
      • Morristown, Tennessee, United States

  • Ball Corporation
    • Dandridge, TN
    • Quality Assurance Manager
      • May 2015 - Aug 2017
      • Dandridge, TN

      - Managed implementation, maintenance, and ongoing improvement of the food safety system (SQF).- Developed Quality System and HACCP plan for new department/ technology.- Lead Spoilage reduction through Spoilage teams, HFI Investigations and lead plants Wildly Important Goals for Quality - Managed plant customer relations. - Managed non-conformances, through CAPA and continuous improvement, fostering cross functional involvement. (9 Step; Customer Visit’s)- Drove Six Sigma methodologies through yellow belt training and mentoring.- Validation of new product specification and plant equipment set, managing all deviations and change requests to corporate - Responsible for Quality process and change management Risk Assessment including disposing all suspect and trial materials

    • Germany
    • Motor Vehicle Manufacturing
    • 700 & Above Employee
    • Senior Quality Engineer
      • Jul 2013 - May 2015

      -Customer management by ensuring maintenance of portals (Toyota supplier/ Covisint (Ford, GM)/ Nissan) 8D’s PCRs, and New Model Launch activities -Lead Plant’s APQP efforts by supporting (PPAPs, PSWs PFEMA’s, controls plans etc.)-Reduce PFMEA/RPN by developing and maintaining control plans and develop RPN tracking and reduction program. Drive for completion of action items to reduce RPN numbers.-Develop and maintain control plans while determining and implementing the best practices. -Responsible for maintaining Six Sigma standards management & APQP, MSA, SPC, TS16949-Drive compliance to TS16949 standards responding to internal and external audit findings, conduct G54, LPA, E211, etc. audits-Manage NCTs and PPM, through CAPA and continuous improvement activates, fostering cross functional involvement -Maintain customer relationships, through resolution of customer complaints, acting as expeditiously and ensuring that effective countermeasures are implemented.

    • Customer Quality Specialist III
      • Dec 2012 - Jul 2013

      -Managed quality staff, ensuring timely project completion daily activities-Responsible for statistical analysis and quality control method implementation-Responsible for Quality Six Sigma standards management & APQP, MSA, SPC, TS16949 -Managed DMR (Decrepit Material Reporting) in TFV plant, ensuring all material was investigated and guided disposition to customer specifications. -Managed all gauging and measurement equipment, procedures and requirements-Develop and implement new gauging solutions including vision systems, auto gauging, etc.-Customer relations liaison responsible for adherence to customer specifications, through management of gauging laboratory, inspection criteria and dispositions. -Benchmark other plants quality systems inside and outside TRW for best practices to implement

  • Colgate Palmolive
    • Morristown, TN
    • Senior Chemist/Senior Stability Chemist
      • Jun 2008 - Oct 2012
      • Morristown, TN

      -Manage laboratory projects, and laboratory resources to meet production needs and Stability needs -Coordinate with production to quickly resolve problems and keep production running-Document operations through investigation (process & CAPA), SOPs, NODs, and training presentations-Mentor and coach analytical staff (development, qualification, and conflict resolution)-Conduct cost analysis, budgeting, PO generation and efficiency evaluations, 2010 cost savings of 165K-Development of validation protocols and execution for new product formulas and compliance risk -Release of intermediate and final products, ensuring compliance of all of documentation and process. -Provide support for FDA inspections, including meeting with auditors and providing plant tours.

    • Business Instructor
      • Jan 2004 - Nov 2007

      -Monitored and mentored students in self-paced MS Office application classes-Developed and Taught business-related classes in a stand-and-deliver format-Assisted with curriculum updates and state educational audits

  • Pfizer
    • Groton, Connecticut
    • Associate Scientist
      • Jul 2001 - Oct 2007
      • Groton, Connecticut

      -Performed instrumental QA testing of stability samples in accordance with cGMPs with strict deadlines, while using a vast array of analytical equipment, utilization of clean rooms, and nitrogen hoods -NDA application testing of inhalable products & delivery system device (effectiveness & leachable) -Troubleshoot equipment , performed product investigations, root cause and corrective action plans -Documented laboratory operations to comply with FDA regulations (cGMP / cGLP) -Evaluated and updated operating procedures to fit current needs-Manage Technical transfer of methods and qualification of methods

Education

  • 2005 - 2007
    Rensselaer Polytechnic Institute
    Master of Business Administration (MBA), Business
  • 1992 - 1996
    University of Massachusetts, Amherst
    Bachelor of Science (B.S.), Environmental Science (Toxicology)
  • 1992 - 1996
    University of Massachusetts, Amherst
    Minor, Chemistry
  • University of Tennessee-Knoxville

Suggested Services

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Industry Focus. “Pharmaceuticals”

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