LAKELA MAYE
Semmes,AL
Summary
Lean Six Sigma Black Belt-certified Operations Leader experienced in driving operational improvements across diverse industries. Led cross-functional teams to enhance quality systems, manage CAPA projects, and optimize processes, resulting in significant improvements in manufacturing reliability and regulatory compliance. Focused on delivering measurable business results through sustainable Lean manufacturing solutions and effective stakeholder engagement.
Overview
1
1
Certification
4
4
years of post-secondary education
14
14
years of professional experience
Work History
Quality Assurance Manager
Jubilant Radiopharma
2023.02 - Current
- Directed CAPA, deviation, and change management projects that reduced recurring quality issues and strengthened operational performance.
- Directed continuous improvement projects to bolster manufacturing reliability, operational excellence, and regulatory readiness.
- Led cross-functional quality improvement initiatives involving Manufacturing, Engineering, Quality Control, Validation, Regulatory Affairs, and Operations.
- Enhanced quality system effectiveness through streamlined SOPs, batch documentation, and inspection readiness activities.
- Facilitated root cause investigations using structured problem-solving methodologies to eliminate process failures.
- Created performance metrics, quality dashboards, and operational scorecards to track compliance and business performance.
- Collaborated with leadership to improve production efficiency while maintaining cGMP and FDA compliance.
Project Manager
Parsons Corporation
2020.06 - 2023.06
- Managed multiple enterprise industrial improvement projects simultaneously from planning through execution.
- Led multidisciplinary teams of engineering, operations, environmental personnel, contractors, and clients to achieve project goals.
- Led multidisciplinary teams consisting of Engineering, Operations, Environmental, contractors, and clients.
- Coordinated executive stakeholder meetings to communicate project progress, address barriers, and align on strategic objectives.
- Developed process improvements to enhance operational efficiency, ensure regulatory compliance, and optimize project performance.
- Utilized SAP and Microsoft Project to monitor project portfolios, budgets, and timelines.
Quality Control Chemist
FMC Corporation
2018.06 - 2020.02
- Led laboratory process improvement initiatives that enhanced analytical efficiency and reduced turnaround times.
- Identified equipment reliability improvements through preventive maintenance efforts and continuous improvement projects.
- Collaborated with Production and Engineering to improve manufacturing quality and reduce process variation.
- Supported Lean initiatives to streamline workflow, boost laboratory productivity, and enhance operational performance.
- Identified equipment reliability improvements through preventive maintenance and continuous improvement initiatives.
Quality Assurance / Food Safety Technician
The Coca-Cola Company
2014.02 - 2017.03
- Facilitated Lean manufacturing initiatives, enhancing efficiency in high-volume production operations.
- Worked closely with Operations to improve manufacturing efficiency and food safety.
- Collaborated with Operations to enhance food safety measures and streamline manufacturing processes.
- Conducted root cause investigations, leading to effective CAPA implementation and corrective action strategies.
- Supported Lean manufacturing initiatives within high-volume production operations.
Quality Laboratory Supervisor
Polaris Laboratories
2012.05 - 2014.02
- Led ISO 17025 laboratory operations, managing team of laboratory professionals to ensure compliance and quality.
- Enhanced laboratory efficiency by standardizing processes and implementing continuous improvement initiatives.
- Developed standardized work procedures and trained staff on quality systems and laboratory best practices.
- Improved laboratory efficiency through process standardization and continuous improvement.
- Fostered culture of operational excellence and accountability among staff, driving continuous improvement across laboratory functions.
Education
Bachelor of Science - Biology & Environmental Science
Alabama A&M University
Normal, AL 2008.08 - 2012.05
Skills
- CAPA
- Root Cause Analysis
- Continuous Improvement
- Lean Six Sigma Black Belt
- DMAIC
- Kaizen events
- Kaizen Facilitation
- Value Stream Mapping
- Process flowcharting
- KPI Development
- Standard operating procedures
- Visual controls
- Operational Excellence
- Risk Management
- Project Management
- Budget oversight
- Minitab
- Analytical Method Validation
- Quality Control Testing
- Instrument Calibration
- Spectroscopic Analysis
- Moisture Analysis
- Laboratory Information Management
- LIMS
- Quality Tracking Systems
- Document Management
- Chromatography Software
- Change leadership
- Cross-Functional Leadership
- Stakeholder engagement
- Microsoft Office
Certification
- Lean Six Sigma Black Belt
- OSHA 30-Hour
- CGMP & 21 CFR Part 11 Compliance
- Radiation Safety (ALARA)
- CPR & First Aid
- ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) - Candidate
Selected Career Achievements
- Led cross-functional quality and operational improvement initiatives across pharmaceutical, chemical, environmental, and food manufacturing operations.
- Managed complex projects involving Engineering, Manufacturing, Quality, Regulatory Affairs, and Executive Leadership.
- Successfully supported multiple FDA and regulatory inspections with zero critical observations.
- Implemented continuous improvement initiatives that enhanced operational efficiency, compliance, and product quality.
- Managed quality systems supporting cGMP, ISO, FDA, and environmental regulatory requirements.
- Recognized for building collaborative relationships across Operations, Engineering, Supply Chain, and Executive Leadership.
Timeline
Quality Assurance Manager
Jubilant Radiopharma
2023.02 - Current
Project Manager
Parsons Corporation
2020.06 - 2023.06
Quality Control Chemist
FMC Corporation
2018.06 - 2020.02
Quality Assurance / Food Safety Technician
The Coca-Cola Company
2014.02 - 2017.03
Quality Laboratory Supervisor
Polaris Laboratories
2012.05 - 2014.02
Bachelor of Science - Biology & Environmental Science
Alabama A&M University
2008.08 - 2012.05