Summary
Overview
Work History
Education
Skills
Websites
Certification
Publications
Timeline
Generic

Shannon C. Walker

Browns Summit,USA

Summary

Quality assurance professional with extensive experience in ensuring product integrity and compliance. Known for driving process improvements and fostering collaborative team environments to achieve results. Skilled in risk assessment, regulatory adherence, and adaptable to evolving project demands.

Overview

31
31
years of professional experience
1
1
Certification

Work History

Senior Quality Assurance Manager

Banknote Corp Of America
01.2025 - 02.2025

Company Overview: Manufacturer of printed high security governmental documents, USPS, states and other counties.

  • Received US governmental and USPS security clearances.
  • Developed clarifying role descriptions for the Quality department.
  • Designed a cross-training plan to add bench strength within the Quality laboratory and floor monitoring teams.

North American Director of Quality

SMURFIT WESTROCK
06.2022 - 01.2025

Responsible for quality oversight of converting sites in the NA network, including managing Regional Quality Managers as direct reports. Maintained quality central ISO 9001:2015 certification for all pharmaceutical/healthcare supplying locations and SQF certifications at food & beverage supplying locations.

  • Led quality assurance initiatives to enhance product standards and compliance with industry regulations.
  • Developed and implemented training programs for staff on quality management systems and best practices.
  • Analyzed quality data to drive strategic decisions, ensuring alignment with organizational goals and objectives.
  • Oversaw audits of quality control processes, ensuring adherence to internal policies and external standards.
  • Mentored team members in quality methodologies, fostering a culture of accountability and excellence within the organization.
  • Led the Regional Quality Manager team and site Quality Managers to reduce part and full rejections by 28% over 2 years, focusing on effective CAPAs of top defect fault codes per trends at each location. Reduced customer complaints by 18% and eliminated 55% of complaints deemed as 'critical' per classification.
  • Improved RFT (Right First Time) quality metric by 1.5% collectively for NA over the period of 2 years.


Regional Quality Manager, April 2019 - June 2022

Responsible for managing a region of 10 pharmaceutical/healthcare/medical device supplying site of secondary packaging materials, including leaflets/inserts, labels and folding cartons

• Managed a team of Quality Managers within a geographical region within the Southeast

• Implemented an eQMS system (Q-Pulse) across the region successfully, resulting in an average time and effort reduction of 25% per Quality Manager with implementation of automation available in the eQMS

• Performed corporate internal audits of sites within the region and of suppliers

• Implemented harmonized metrics across sites which were comprised of 4 legacy companies and independent ways of working

Director of Quality

PACKRITE LLC
10.2018 - 04.2019
  • Company Overview: Manufacturer of premium microfluted & folding cartons
  • Manages all site quality systems, including certifications, corrective & preventive actions, document and change control, validation, material acceptance criteria, incoming, in-process and final product release.
  • Achieved ISO 9001:2015 2 Day Surveillance audit without observations/findings
  • Introduced root cause analysis tools including A-3, fishbone and ABS Root Cause Analysis
  • Implemented Tier meetings to review daily results for safety, quality, production/cost and delivery KPIs
  • Designed a Layered Process Audit (LPA) system

Manager, Quality

PAPERWORKS INDUSTRIES, INC.
01.2017 - 01.2018
  • Company Overview: Secondary packaging supplier to health, personal and beauty care clients
  • Manages all site quality systems servicing FDA regulated customers in a GMP compliant environment. Responsible for establishing quality parameters for product trials and new business on-boarding. Manages and develops site quality team with responsibilities of document control, corrective & preventive action system, incoming materials review, equipment calibrations, in-process controls, and final review and release of packaging products.
  • Transforming Quality Management System to an ISO 15378:2017 based system for primary packaging intended for medicinal products with a concentration of cGMP compliance.
  • Developed and implemented a change control system to maintain proper compliance of processes and equipment.
  • Designed and implemented a validation program for new or modified equipment including design, installation, operation and performance qualification elements.
  • Reduced external cost of poor quality from a monthly average of $10,280 to a current average of $2,030 through improved process controls and procedures.
  • Improved the quality and effectiveness of nonconformity investigations by implementing A-3 root cause failure analysis tools and teams.
  • Built strategic customer relationships by initiating onsite and conference-based reviews.
  • Implemented a supplier qualification program and quality performance system.
  • Deployed the site's first cGMP training program to elevate GMP compliance of personnel and facility.
  • Designed a Layered Process Audit (LPA) system for enhancing verification of quality, safety and operational requirements.
  • Implemented Asset Performance Trending & Focused Kaizen Events.
  • Implemented Leader Standard Work, Equipment Centerlines, Standard Work Instructions & One Point Lessons to standardize work processes to achieve consistent output.

Vice President, Quality

MM Group (f/k/a Essentra Packaging)
01.2011 - 01.2017
  • Company Overview: Secondary packaging supplier of folding cartons, leaflets/inserts, cards, pressure sensitive labels and specialty products to pharmaceutical, medical device & healthcare clients
  • Managed and improved all facets of quality management and training systems in compliance with cGMPs, PS 9000, ISO 9001, and customer requirements. Oversaw development, deployment, and effectiveness of quality procedures and process training. Owned supplier and service providers' qualification and performance. Served as customer contact for quality and service issues, and continuous improvement thereof.
  • Realized reduction in customer complaints and cost of poor quality of 10% through focused improvement projects.
  • Developed a harmonized metrics system for quality performance and training effectiveness.
  • Implemented training matrices for skill assessments and continual advancement of employee knowledge.
  • Led organization to improve process flow, resulting in 12% increase of on-time and in-full shipments to customers.
  • Achieved 100% success rate of customer audits and ISO 9001, PS 9000, and SFI/FSC certifying audits
  • Improved customer-facing role requirements, increasing customer response time by 33%.

Director of Quality

Essentra (fka CLONDALKIN PHARMA & HEALTHCARE)
01.2006 - 01.2011
  • Managed quality budget and staff of QA managers, Engineers and teams at nine sites specializing in secondary pharmaceutical and healthcare packaging. Oversaw all facets of quality management systems in compliance with cGMPs, PS 9000, ISO 9001, and customer requirements. Led company's Lean manufacturing program, training all sites on Lean principles/tools, leading Kaizen events, and tracking and reporting results to senior management.
  • Created and implemented a corporate quality management system, harmonizing nine sites from five legacy companies.
  • Achieved corporate certification to ISO 9001:2008.
  • Became first and only US Corporation to achieve certification to PS 9000:2011, quality standard designed for manufacturers of packaging intended for medicinal products.
  • Led an average of eight kaizen events annually, including setting up Kanban systems, SMED, value stream mapping sessions and standard work events.

QA Manager

Essentra (fka PHARMAGRAPHICS)
01.2005 - 01.2006
  • Oversaw quality department budget and staff of site QA team. Managed site's quality management system, including management reviews, complaints, root cause investigations, calibrations, documentation and change control, training and process validations, and internal audits. Hosted customer audits. Designed and implemented process and equipment validation program. Implemented supplier quality management program. Created a new quality metrics system to communicate quality KPIs to senior management and site personnel. Reduced customer complaints by 12% through improvement projects in QA and operations.

QA Systems Leader

PROCTER & GAMBLE
01.1994 - 01.2005
  • Managed electronic quality systems, including training end users and developing training programs, standard operating procedures, and troubleshooting guides. Performed quality inspections of incoming packaging materials for compliance to specifications and pharmaceutical/medical device regulations. Oversaw supplier audits and performance management. Developed and executed validations for electronic quality systems. Completed all job functions in compliance to 21 CFR 211 and 820. Participated in FDA routine audits.

Education

Executive Certificate - Business Administration

UNIVERSITY OF NOTRE DAME, MENDOZA COLLEGE OF BUSINESS
South Bend, Indiana
01.2016

Small Business Administration - undefined

NORTHERN ARIZONA UNIVERSITY
Flagstaff, Arizona
01.2015

Information Technology - undefined

PATRICK HENRY COMMUNITY COLLEGE
Martinsville, Virginia
01.2001

Skills

  • SAP QM Module, Microsoft Office Suite, Various MRP Systems, eQMS Systems and Statistical Software
  • Hudson Leadership Training
  • GrowthPlay Sales & Customer Service Training
  • Change Leadership Certification

Certification

  • Certified Lead Management Systems Auditor
  • Lean Six Sigma Green Belt

Publications

  • Featured in Pharma Technology magazine discussing reducing the risks associated with packaging materials in the pharmaceutical industry.
  • Appeared in publications of Plastics In Packaging and Healthcare Packaging for becoming the first North American company in achieving PS 9000 certification as the first company in North America to accomplish

Timeline

Senior Quality Assurance Manager

Banknote Corp Of America
01.2025 - 02.2025

North American Director of Quality

SMURFIT WESTROCK
06.2022 - 01.2025

Director of Quality

PACKRITE LLC
10.2018 - 04.2019

Manager, Quality

PAPERWORKS INDUSTRIES, INC.
01.2017 - 01.2018

Vice President, Quality

MM Group (f/k/a Essentra Packaging)
01.2011 - 01.2017

Director of Quality

Essentra (fka CLONDALKIN PHARMA & HEALTHCARE)
01.2006 - 01.2011

QA Manager

Essentra (fka PHARMAGRAPHICS)
01.2005 - 01.2006

QA Systems Leader

PROCTER & GAMBLE
01.1994 - 01.2005

Small Business Administration - undefined

NORTHERN ARIZONA UNIVERSITY

Information Technology - undefined

PATRICK HENRY COMMUNITY COLLEGE

Executive Certificate - Business Administration

UNIVERSITY OF NOTRE DAME, MENDOZA COLLEGE OF BUSINESS