Senior QA, Operations & Process Improvement Leader

Michelle Burns Page *

Frederick, MD ***** 404-***-**** *****************@*****.*** linkedin.com/in/michelle-burns

SR. QA & Operations Manager

Operations Supervision Quality Assurance Six Sigma Black Belt

Growth-driven professional with a track record of establishing and rolling out modern, strategic, and high ROI quality processes and operational roadmaps to ensure the achievement of set goals. Proven success in identifying new market trends, conducting detailed research, analyzing data, and developing KPIs to expand business products and services. Compassionate leader, directing cross-functional team members to streamline operations, reduce costs, and facilitate business growth. Skilled in resolving and mitigating emergent issues/risks using Lean Six Sigma for better service outcomes.

Trusted advisor to the executive team, consistently delivering significant ROI by applying technology and efficiency solutions while leveraging Lean Six Sigma to enhance business initiatives.

Partnered with associates, leadership, and corporate business partners to ensure timely execution of all initiatives and correspondence, including defining customer deliverables, coordinating schedules, and issuing progress reports.

Successfully scaled organizations while creating deliverables that align leadership development with high performance to support organic growth.

Technical Proficiencies: Microsoft Word & Excel Workday

PROFESSIONAL EXPERIENCE

VaLogic Bio LLC, Frederick, MD MAR 2025 – Present

Facility Services Manager

Project Manager for Repository Services

Supervises a diverse of internal leaders to optimize performance and morale. Drove end-to-end process optimization, including inventory handling, material planning, and production scheduling.

Streamline a safety Program

Oversees daily repository operations including inventory management, GMP material receipt

Maintains repository files for validation of data and preparation of queries; reviews accumulated data for accuracy and prepares reports of information and sample data

ISO & Regulatory compliance (9001, 17025, 27001)

Established and tracked KPIs for audit readiness, certification, calibration, and repository timelines, and corrective actions; achieved 100% audit pass rate and new business.

P&L and budget ownership for Calibration, Certification, and Repository services 2.3 million budget

Lead a global team of 6 certification, calibration, and technical writers’ specialist.

Oversees daily repository operations including inventory management, GMP material receipt

Maintains repository files for validation of data and preparation of queries; reviews accumulated data for accuracy and prepares reports of information and sample data

Oversee a team of calibration specialists ensuring precise equipment maintenance and compliance.

Deliver detailed monthly reports to clients on facility performance and compliance

Draft and negotiate service proposals and contracts

Contributes to the development of and/or creates standard operating procedures for calibration, certification, and safety.

Managed all ISO-17025 certification efforts.

VaLogic Bio LLC, Frederick, MD

Quality Management System Manager

Project Manager for Repository Services (Interim Role): – (2023 – 2025)

Supervises a diverse of internal leaders to optimize performance and morale. Drove end-to-end process optimization, including inventory handling, material planning, and production scheduling. ‘

Streamline a safety Program

Oversees daily repository operations including inventory management, GMP material receipt

Maintains repository files for validation of data and preparation of queries; reviews accumulated data for accuracy and prepares reports of information and sample data

Contributes to development of and/or creates standard operating procedures for repository processes

Resolves complex discrepancies involving ID modifications/duplicate or redundant entries and multi-field corrections as directed by client or Supervisor instructions

Identifies the need for and/or participates in process improvement activities

Verifies material prior to shipment and confirms accuracy of data entry records for incoming materials

Trouble shoots facility equipment issues and provides suggestions and/or solutions for implementation

Implement Quality Management system into production to become ISO 9001 Certified

Implement Quality Management system into production to become ISO 17025 Certified

Established Quality Culture through ongoing development and maintenance of Quality System, including but not limited to Training, Documentation, Deviation Investigation and CAPA, Change Control, Validation, Metrics, and Internal Quality Audits.

Provided Quality and Compliance support for all areas of GxP.

Developed processes to ensure company products and services meet quality standards.

Monitoring and evaluation of internal standard operating procedures and processes.

Overseeing employee performance and inspect product to ensure conformity.

Collaborate with project leaders to discuss solutions to quality issues, investigate causes of quality problems and propose solutions.

Trained to manage SOPs, Methods, Work Instructions, and Specifications, as well as Deviations, CAPAs, Audits, Change Controls, and Complaints.

Conducts reviews, of GMP documents (i.e. Raw Data Reports IQ/OQ/PQ Protocols, Test Reports, Forms, etc.), both internal and external, to ensure compliance with cGDP and cGMP regulations.

Provide insight to improve processes and practices to ensure manufacturing quality is maintained while efficiency is optimized

Conduct staff training on quality procedures, protocols, and documentation to ensure compliance to cGMP requirements.

Provide maintenance and control of Quality Assurance documentation

Conduct investigation when measurements are found to deviate from standards

Wal-Mart Distribution Center, Statesboro, GA 2013 – 2023

Operations Manager – Supply Chain Optimization (2022 – 2023)

Supervises a diverse team of three vendors and internal leaders to optimize performance and morale. Drove end-to-end process optimization, including inventory handling, material planning, and production scheduling. Maximized employee engagement score from 44% to 77% and NPS (Net Promoter Score) from -26 to 2%.

Played a key role in establishing and maintaining annual cost-saving initiatives framework with clear KPIs by monitoring and reporting progress.

Strengthened on time delivery by 50% and increased business engagement quality scores; Instrumental in implanting audit change controls

Shifted trajectory of the outbound operations; Selected to lead the formulation the of people, process, and business procedures to ensure new product introductions, supply chain flow changes, and business transformation.

Oversaw the quality control and distribution services on site, including coordinating and scheduling inspections and tests and supervising personnel.

Touched every aspect of the employee development initiatives; Leveraged leadership and expertise to optimize inventories, material planning, and production scheduling to maximize efficiency and productivity.

Contributed to the enhancement of CPH performance from 78 CPH to 266 CPH through the delivery of exceptional services.

Increased service level performance by 45% and reduced costs by 25% via the identification of opportunities for process improvements.

Quality Assurance Manager (2017 – 2022)

Devised and retained innovative methods to control the quality/reliability of products and services in assigned areas. Supplied reliable, compliant, and high-quality products to customers. Developed quality and testing best practices. Ensured QMS complies with companies KPIs.

Promoted to streamline an effective QA process. Initiated strategic planning process for the team, including prioritizing and scheduling projects for the next 12-18 months, evaluating current strategy and identifying potential risks, and opportunities for the future.

Created and fortified beneficial and long-lasting relationships with local regulatory authorities by certifying adherence to all applicable regulations.

Lead a high-performance QA team; Met quarterly production targets and reduced the number of labor hours by 23% spent within the facility.

Peer mentor for QA Managers within the organization on Leadership, processes, distribution timelines, performance evaluations, root cause analysis, and implementation of corrective actions.

Area Manager – E-commerce Pop-Up (2016 – 2017)

Hired, developed, and increased the efficiency of a team of 15 associates and three team leads concurrently inside a 2.1M sq. ft. Walmart Distribution center. Conducted random audits on processes and generated 1581 (cycle report) and 171 (cycle report) while transferring data from the LVVR report to resolve quality issues on regular basis.

Decreased shrink by 12% and enhanced production by 35% through effective management of quality assurance processes in collaboration with quality team.

Volunteered to serve as a project lead to rolling out pop-up e-commerce locations. Developed strategies and tech solutions that resulted in e-commerce achieving number 1 in the network.

Drove operational efficiency by overseeing business plans for inbound and outbound operations and implementing state-of-the-art technology.

EDUCATION

Master of Business • University of West Georgia, Carrollton, GA (Ongoing)

Bachelor in Sociology • University of West Georgia, Carrollton, GA (2015)

Six Sigma Black Belt Certification 119493349 (2022)

5S Concept Certification 142391511 (2022)

KEY VALUE ADDS

Performance Evaluation

Process Optimization

Project Lifecycle Management

Regulatory Compliance

Warehouse Management

Systems Inventory Control

Employee Learning & Development

Stakeholder Engagement

P&L Management

Supply Chain Operations

Business Transformation

Client Services & Satisfaction

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