Napoleon Stephney
Nesbit,USA
Summary
I have 17 years of experience as in GMP Quality/Compliance experience adhering to strict FDA regulations. I have two years of managerial experience. I have a Six Sigma Green and Yellow Belt with experience using 5s, Kaizen and DMAIC methodologies. I am looking to further my career with a great company utilizing my past work experiences.
Overview
24
24
years of professional experience
1
1
Certification
Work History
Quality Supervisor
Henkel Adhesives
06.2021 - Current
- Manages lab inventory and lab supply budget and on-going savings projects.
- Serves as subject-matter expert for SAP and WMS hold processes for quality.
- Oversees product traceability and plant traceability exercises and documentation.
- Provides support for investigating quality issues, escalating problems when needed, and recommending improvements or product dispositions.
- Prepares reports, analyzes data, and leads efforts for improving operations and problem solving.
- Maintains and facilitates quality training for new hires.
- Investigates and resolves consumer and customer complaints and returns.
- Assists in implementing quality assurance work processes and systems across the plant site.
- Manages plant hygiene processes, sampling and testing raw materials, process water, bulk and finished goods, and packaging lines to identify microorganisms and contamination sources.
- Performs quality audits in the plant, warehouses, or at suppliers and supports third-party audits, inspections, and corporate visits.
Memphis Division Manager
Invitrix Therapeutics
04.2019 - 01.2021
- Supervised and managed employees, prepared schedules, and assigned duties.
- Ensured compliance with FDA regulations and health and safety standards, including documentation and inspection oversight.
- Oversaw all Memphis site functions including inbound and outbound shipments, inventory control, and logistics.
- Achieved quality objectives by investigating problems and implementing improvements.
- Communicated with management about challenges related to shipments, logistics, and inventory.
- Implemented best practices across Orders Group functions.
- Reviewed donor information for compliance and customer specifications.
- Reviewed and signed off on all orders.
- Scheduled instrument calibration and maintenance and ordered supplies.
Quality Control Chemist
McKesson RX Pak
05.2018 - 04.2019
- Performed qualification and advanced maintenance of laboratory instrumentation and equipment.
- Drafted and executed validation protocols and wrote SOPs.
- Analyzed data and maintained laboratory notebooks according to cGMP and internal guidelines.
- Reviewed and audited documentation and work by other laboratory analysts.
- Trained and guided less experienced analysts.
- Maintained compliance with USP, FDA, OSHA, GMP, and GDP requirements.
- Scheduled instrument calibrations and ordered lab supplies.
Quality Control Chemist (Contractor)
Valero Oil Refinery
03.2017 - 02.2018
- Trained new chemists on environmental testing.
- Analyzed refinery samples for H2S, sulfur, residue, and other critical metrics.
- Performed troubleshooting and maintenance on GC equipment.
- Monitored refinery waste water streams for oil, grease, TSS, phenols, ammonia, BTEX, and COD.
- Reported out-of-specification results to management.
- Utilized LIMS, EZ Chrome, and Lab Workbench software.
Chemist Analytical Stability
Bayer HealthCare LLC
11.2003 - 12.2016
- Conducted complex analytical experimentation independently.
- Trained analysts in sample testing and instrumentation qualification.
- Authored and reviewed SOPs for laboratory processes.
- Investigated out-of-specification results and developed CAPAs.
- Served as Chemical Hygiene Officer, completing safety audits.
- Administered Mylearning Training System.
- Utilized SAP, Empower, and Minitab for data management and analysis.
Environmental Chemist
Environmental Testing & Consulting
01.2003 - 11.2003
- Generated data using soil, water, and product analysis with wet, inorganic, and organic chemistry techniques.
- Conducted instrument troubleshooting, maintenance, and calibration.
- Participated in regulatory audits and competency evaluations.
- Performed analysis as required by EPA SOPs.
Quality Assurance Chemist
Cargill
08.2001 - 12.2002
- Maintained quality control over corn syrup and finished product samples to meet food safety standards.
- Monitored quality management systems including calibration, raw materials, and training.
- Assisted with bench trial runs for new products and customers.
- Conducted root cause analysis, trend identification, and corrective actions.
Education
Masters of Business Administration -
University of Phoenix
Memphis, TN12.2007
Bachelor of Science - Chemistry
Alcorn State University
Lorman, MS05.2001
Skills
- Quality training
- Dedication to product quality
- Quality management systems
- Systems analysis
- Corrective action planning
- Quality control management
- Auditing techniques
- Product testing
- SAP software
Certification
- Sigma Green Belt
- January 2014 to Present
- Sigma Yellow Belt
- March 2012 to Present
Timeline
Quality Supervisor
Henkel Adhesives
06.2021 - Current
Memphis Division Manager
Invitrix Therapeutics
04.2019 - 01.2021
Quality Control Chemist
McKesson RX Pak
05.2018 - 04.2019
Quality Control Chemist (Contractor)
Valero Oil Refinery
03.2017 - 02.2018
Chemist Analytical Stability
Bayer HealthCare LLC
11.2003 - 12.2016
Environmental Chemist
Environmental Testing & Consulting
01.2003 - 11.2003
Quality Assurance Chemist
Cargill
08.2001 - 12.2002
Bachelor of Science - Chemistry
Alcorn State University
Masters of Business Administration -
University of Phoenix