Quality Control A Team

SUMMARY

Outgoing, detail-oriented chemist with keen critical thinking and analytical skills. Strong interpersonal, planning, and organizational skills as demonstrated by continuous expansion in responsibility.

Contribute independently, or as part of a team, to coordinate and manage projects.

Leadership abilities. Consistently gained increased responsibility through employment history and academic pursuit culminating in supervising a team of technicians.

SKILLS

Certified Quality Auditor (CQA)

Six Sigma Green Belt

Medical Devices

Paper lamination and coatings

Rubber Formulation

cGMP

ISO13485

ISO14001

ISO9001

ISO45001

FMEA

CAPA

WORK EXPERIENCE

Motion Industries – Birmingham, Alabama January 2024 – January 2025

Quality Assurance Manager, DC/FC

ISO9001: managed and implemented new quality systems for multiple sites across North America.

Process Improvement: Reduced travel cost by 50% by creating an easy-to-follow guide for ISO9001 implementation at new sites.

Process Creation: Created and implemented brand new processes such as customer complaints/feedback, internal audits, CARs, etc.

HAZMAT: reduced risk exposure by creating a receiving process to check for HAZMAT status, running gap assessments for training, and working with cross functional teams to

Risk: discovered gaps in our risk management program and developed new FMEAs

CAPA: Created and implemented new CAPA processes. Assisted sites with root cause investigation.

eQMS: lead a project to bring the company up to the date with current technology by championing an eQMS program creating by in across the company the brought the project over the finish line.

Specification Rubber Products – Alabaster, Alabama December 2022 – December 2023

Quality Manager

Led cost cutting initiatives including taking control of nonconforming incoming materials and performing 5S initiatives throughout the facility.

Managed and maintained ISO9001 QMS and calibration program of critical instrumentation.

Orchestrated annual sampling plans, documentation and certifications for UL and NSF61.

Developed and maintained SOPs, including creating a process for controlled documents.

Collected and analyzed data using SPCs methods for continuous improvement of process and materials.

Created quality information boards to post throughout the plant to educate the workforce on the products they make.

Identified and analyzed the root cause of chronic operating issues and proposed solutions.

Provided customers with expert technical support with root cause analysis of compound issues on both the compound and processing sides.

Lead the quality control technicians, including mediating interpersonal conflicts, timecard and scheduling issues, and upheld HR and attendance policies

Organogenesis – Birmingham, Alabama October 2021 – November 2022

Validation Engineer II

●Built a validation program at the Birmingham site, including obtaining equipment and writing a very detailed procedure from scratch for equipment and process validations.

●Prepared protocols and reports for validation (IQ, OQ, PQ), requalification, and revalidation work.

●Created a requalification plan and schedule to ensure validation compliance.

●Coordinated and executed validation studies for equipment including controlled-temperature units (Ultra low temperature freezers and refrigerators).

●Used Kaye V2K, DataTrace data loggers, and SenseAnywhere validation equipment.

●Performed testing using standard concepts, practices and procedures of the cGMP process.

●Prepared, reviewed and summarized equipment history files to assess the validated state of the equipment.

●Authored and revised SOPs, including CAPA, deviation, and facilities and equipment management.

●Aided with CAPA management including preparing CAPAs for closing and verification of effectiveness checks.

●Performed gap assessments with FDA regulations and ISO13485 and aided in closing the gaps found in the processes.

BioGX – Birmingham, Alabama February 2021 – October 2021

QA Specialist, Quality and Regulatory Affairs

●Maintained tracking to allow for proper corrections of internal and external audit major/minor non-conformances and improvement observations in accordance with ISO13485 Standards

●Lead Audit Program Management and execution

●CAPA management for the site

●Managed FMEA and risk management initiatives across departments.

●Managed local Q&R processes and ensured process ownership for all activities under the QMS governance in scope

●Assisted all department Management personnel in the development of systems to comply with ISO13485 and FDA Regulations

●Developed training packages and delivered training for process/document content managers

●Developed and managed document control systems

●Management of ISO13485 Quality Management System

●Reviewed process and documentation to ensure quality frameworks, forms, references and links were established

●Supported administrative resources across the organization to ensure consistency, linking process and documents, removal of duplication and provide advice on efficiency related matters

●Maintained equipment IQ/PQ/OQs, calibrations, and PMs.

Cascades Sonoco – Birmingham, Alabama February 2020 – November 2020

Technical Manager

●Oversaw the lab to market process of several multimillion dollar product lines.

●Helped develop and roll out strategic projects on the water-based product line and extrusion line.

●Collaborated with the quality department to start a HACCP program for the facility, including creating the Crisis Communications Guide.

●Maintained chemical inventories resulting a 50% reduction in chemicals through control of purchasing, monthly cycle counts, and disposal.

●Managed the product development process of the plant, including implementing proper record keeping protocols.

●Collected quotes for needed products and projects.

●Assisted Chief engineer in scheduling, planning, and managing Cap Ex projects, namely, the finishing touches on the multimillion dollar dual coating machine.

●Supervised new product trials by preparing trial protocols, document machine parameters and shared conclusions and recommendations to the team.

●Provided technical assistance to clients and business partners

Mountville Mills Rubber Company – LaGrange, Georgia February 2019 – February 2020

Quality Supervisor

●Collected and analyzed data using SPCs methods for continuous improvement of process and materials.

●Identified and analyzed the root cause of chronic operating issues and proposed solutions.

●Provided customers with expert technical support with root cause analysis of compound issues on both the compound and processing sides.

●Lead the quality control technicians, including mediating interpersonal conflicts, time card and scheduling issues, and upheld HR and attendance policies.

Plant Chemist

Main responsibilities of position were to meet customer’s expectations and requirements by developing rubber compounds, scale-up and optimization of production methods, and report project status to both management and customers. oversee the daily operations of research and development. Successfully implanted a system to track and catalogue R&D projects. Managed and created new recipes in Mesabi production system, including mix procedures, batch weights, and fill factors.

●Troubleshoot and provided technical support to the production supervisors and operators.

●Oversaw the transition of compounds from R&D to full scale production, including visits to customer to observe the performance of our products.

●Collaborated with Materials Manager for cost optimization of materials and compounds.

●Implemented a naming scheme for internal compounds.

HEXPOL Compounding – Kennedale, Texas April 2016 – February 2019

Process Chemist

Main responsibilities of position were to formulate rubber recipes based on customer needs and requirements, provide customers with expert technical support with root cause analysis of compound issues on both the compound and processing sides, oversee the daily operations of R&D, scale-up and optimization of production methods, and report project status to both management and customers.

●Lead auditor for ISO 9001:2015 and ISO 14001:2015.

●Assisted Quality manager in assuring our compliance in rainwater runoff, waste water, and air quality.

●Planned and implemented safety procedures with safety committee for R&D and production.

●Managed the labs stock room inventories including labeling, cataloguing, disposal, and purchasing.

●Collected and analyzed data using SPC methodology for continuous improvement of process and materials.

●Provided key technical support and project management to save a $5 million/year project.

●Identified and analyzed the root cause of chronic operating issues and proposed solutions.

●Troubleshoot and provided technical support to the production supervisors and operatives.

EDUCATION

Master of Science in Chemistry May 2016

●University of Texas at Dallas - Richardson, Texas

●GPA: 3.55

Bachelor of Science in Chemistry with ACS Certification May 2014

●University of Texas at Tyler - Tyler Texas

●GPA: 3.90 - Magna Cum Laude

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