Michael Harris
Lititz,PA
Summary
Manufacturing professional with extensive experience in GMP production, quality systems, and continuous improvement initiatives within regulated environments. Proven ability to drive process improvements, perform root cause investigations, and partner with cross-functional teams to enhance operational performance. Strong background in data analysis, compliance, and shop-floor engagement, with hands-on experience supporting Lean, Six Sigma, and reliability-focused improvements.
Overview
16
16
years of professional experience
Work History
Quality Assurance Specialist II
Kenvue
Lititz, PA
11.2022 - Current
- Partner with operations and cross-functional teams to identify and resolve production, quality, and process issues, supporting continuous improvement initiatives
- Conduct detailed investigations and root cause analysis on consumer complaints and manufacturing deviations
- Perform GMP walkthroughs and assessments, identifying opportunities for process, safety, and equipment-related improvements
- Support loss elimination efforts by identifying recurring issues in batch records and production documentation
- Review production, packaging, and lab records to ensure compliance and process consistency, helping reduce variability
- Contribute to inspection readiness and risk identification, prioritizing safety, quality, and operational risks across the site
- Utilize SAP, Maximo, and LIMS systems to support data tracking, issue resolution, and performance monitoring
- Key Achievements:
- Recognized as SME for customer complaint investigations, driving improvements in issue resolution and trend analysis
- Active member of Inspection Readiness Team, identifying and mitigating plant risks impacting performance and compliance
Aseptic Manufacturing Lead Operator
GlaxoSmithKline
Marietta, PA
01.2017 - 11.2022
- Led day-to-day operations of aseptic manufacturing and filling processes, ensuring equipment reliability and process consistency
- Supervised and coached operators, reinforcing standard work, safety practices, and operational excellence principles
- Identified and resolved process inefficiencies, supporting continuous improvement and production reliability
- Ensured strict adherence to SOPs and GMP standards, minimizing deviations and production downtime
- Supported operational performance by troubleshooting issues and collaborating with maintenance and quality teams
- Played a key role in maintaining stable operations during high-demand and constrained staffing conditions
- Key Achievements:
- Received multiple awards for problem-solving, operational support, and maintaining production continuity
- Recognized for leadership during staffing shortages and contributing to safe, reliable production execution
Lab R&D Scientist
DuPont
Wilmington, DE
03.2010 - 04.2017
- Supported manufacturing and R&D operations by troubleshooting processes and identifying performance improvements
- Participated in Lean, Six Sigma, and Kaizen initiatives to optimize production processes and reduce inefficiencies
- Provided technical support to manufacturing by identifying root causes of process variation and recommending improvements
- Developed and maintained SOPs and batch records to ensure process control and consistency
- Operated pilot-scale equipment supporting process scale-up and manufacturing readiness
- Key Achievements:
- Led scale-up initiatives for polymer synthesis processes, improving manufacturing readiness and efficiency
Education
Bachelor of Science (B.S.) -
University of Delaware
Newark, DESkills
- Continuous Improvement (Lean, Six Sigma, Kaizen)
- Root Cause Analysis & Investigation
- GMP Manufacturing & Compliance
- OEE Awareness & Loss Identification
- Process Improvement & Standard Work Development
- Cross-Functional Collaboration
- Operator Training & Coaching
- SAP / Maximo / LIMS Systems/Veeva
- Data Analysis & Reporting (Excel)
- Risk Assessment & Problem Solving
Timeline
Quality Assurance Specialist II
Kenvue
11.2022 - Current
Aseptic Manufacturing Lead Operator
GlaxoSmithKline
01.2017 - 11.2022
Lab R&D Scientist
DuPont
03.2010 - 04.2017
Bachelor of Science (B.S.) -
University of Delaware
ADDITIONAL CAPABILITIES
- Strong ability to work between shop floor and leadership
- Experience training and mentoring operators
- Skilled in prioritizing work in fast-paced manufacturing environments
- Comfortable working in regulated, high-performance production settings