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JAMIE HAIRSTON

**** ***** ****** **, ****** City, Texas 77573 Cell: 979-***-****

ad18c2@r.postjobfree.com

PROFESSIONAL SUMMARY

Skilled Quality Assurance/Quality Control Manager with 10+ years’ experience in Quality Control, Management and Improvement across multiple industry settings including Manufacturing, Research and Development, Analytical Sciences, Biomedical/Medical. Well-organized, results oriented individual with proven ability to implement standards, procedures and processes that improve business functionality. SKILLS

Strong work ethic

Project management

Knowledge of quality tools as defined by ASQ

Quality Assurance & Quality Control

Laboratory analysis

Document control, SAP, LIMS systems tools

Experience in ISO 9001:2008 and 2015, cGMP,

NSF standards and certifications

Lead quality auditor

Cross-functional Team Leadership

Continuous Improvement

WORK HISTORY

Site Quality Management Representative, 04/2019 - Current Lyondellbasell La Porte Complex– La Porte, TX

Quality Liaison for multiple site Chemical and Polymer units. Integrating new HDPE unit into site Quality Management Systems and led plant through gap assessment and closure to achieve ISO 9001:2015 and NSF Std-51 & 61 Certifications. Targeting certification 3Q2023. Implemented gap closure plan to address document control issues across site documents and procedures by restructuring into format that achieved site uniformity, compliance against ISO 9001:2015 and Corporate Quality Document Control requirements. Eliminated Document Control non-conformities and achieved GOALZero Audit Performance in 2020 External ABS ISO Re-certification Audit. 2

Led Process & Quality Improvement Team to increased product quality performance from 3rd quartile PTAI to 2nd Quartile PTAI rating by reducing the number of prime lot misses in LDPE units. Site Chemicals Quality Manager, 04/2016 to 06/2018 Dow Chemical Company – Seadrift, TX

Quality Liaison for 6 site chemical production units, site logistics area and dedicated analytical laboratory facility across multiple businesses for DOW Industrial Solutions. Maintained the facilities quality policy, manual, processes, procedures and related documents to verify compliance against industry codes, standards and regulations. Ensured production processes met all in-process, finished production, sales and customer specifications for 45+ products to include Glycol Ethers, Ethanolamine and Heavy Esters. Developed job description and directly supervised Site Quality Technologist / Production Data Analyst resource to support operations.

Led internal, external and customer quality control audits to assess and validate multiple facilities quality management systems against certification requirements. Managed multiple business ISO certificates. Led the ISO certification project and successfully transitioned all unit quality management systems from ISO 9001:2008 standard to the new ISO 9001:2015 standard and requirements. Developed Quality Network Team and led re-occurring meetings to drive continuous improvement. Led document control project to convert all controlled documents within (WebEDMS and Documentum) document control system to pdf renditions to reflect uncontrolled when printed as per ISO document control requirements.

Led several raw material qualifications and six sigma customer request driven projects with cross functional Supply Chain, Purchasing, Product Steward, Tech Service & Development representatives to support business cost savings and improvements efforts. Raw material qualification contracts ~ 1.2M cost savings.

Developed quality KPI's and generated quarterly quality metric reports for business customer success team meetings.

Set department objectives and goals for Quality section of Management Improvement Plan. Managed and resolved all product quality related customer complaints and notifications in the Corrective Action Management Program database in a timely, professional manner. Developed and implemented a decision tree work process procedure to assist with troubleshooting and resolving day-to-day product quality data flow interface issues between the Laboratory Information Management System (LIMS) and SAP systems which reduced shipment delays and carrier demerge charges by ~25%.

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Implemented Focus EMI- real time based program for operations to control chart and trend critical process parameters and specifications on final products which increased first pass prime percentages across all plants.

Facilitated formal product quality related Root Cause Investigations (RCI), documented corrective and preventative actions and validated effectiveness of actions in Event and Action Tool. External Manufacturing Quality Systems Specialist, 02/2011 to 04/2016 Dow Chemical Co – Freeport, TX

Quality focal point for 25+ contract / toll manufacturing facilities globally for the production of Glycol Ether products.

Conducted periodic quality control audits against Operations Plans and contracts to ensure compliance against DOW expectations and requirements.

Maintained existing quality sections of Operations Plans and developed the quality section of new Operations Plans.

Created new contract specifications in the Specification Repository through the Change Management Tool. Generated quality metric reports and participated in periodic Performance Reviews of each facility as directed by Business External Manufacturing Leader. Led BHT inhibitor addition in railcars improvement project and Low Metals grade production project increasing volume and sales on 2 KTA contracts by $900K/yr. Managed and resolved product quality related customer complaints on all products produced at contract manufacturing facilities.

Led 15+ new project start up efforts with support from cross functional business Supply chain, Purchasing, Marketing, Product Steward reps.

Led specification gap analysis project to identify and resolve specification misalignments between current contract manufacturing specifications and specifications documented in facility Operations Plans in support of Milestone 5 NEA Specification Repository database upgrade. Supported Milestone 5 NEA implementation for transition to new Specification Repository and SAP systems.

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Lead Chemist/Toxicologist & QA/QC Manager, 05/2009 to 02/2011 Brazoria County Crime Laboratory – Angleton, TX

Performed routine qualitative and quantitative analysis of controlled substances by GC/MS, Microcrystalline and various wet chemistry tests.

Conducted drug screening on urine and blood specimens using Immunoassay. Performed blood alcohol analysis by headspace GC- FID. Led back log reduction project completing blood analysis on 2 years of pending back log cases. Maintained QC logbooks for analytical balances, GC instruments, refrigerators and freezers; troubleshoot instrument issues.

Supported method development and validation projects. Prepared final reports of results and served as second level reviewer for other employees’ casework. Testified as an expert witness in criminal cases.

Maintained the laboratories quality management system and ASCLAD LAB certification. Research Laboratory Supervisor, 08/2006 to 06/2007 Texas A&M University – College Station, TX

Coordinated the startup of a new research laboratory at the Texas A&M Vet School- Department of Vet Physiology and Physiology on time and within budget. Conducted day-to-day research activities focused on the effects of apoptosis on reproduction and cancer using transgenic mouse models.

Trained and supervised 10-20 undergraduate students per semester. Responsible for laboratory budget, ordering lab supplies and equipment. Communicated with sales representative and instrument technicians as needed Performed DNA/molecular biology techniques such as: PCR, RT-PCR (genotyping), cloning, transfection and transformation of cells, sequencing, immunohistochemistry, and gene mapping; tissue culturing of Embryonic stem cell lines.

Established and maintained large mouse colonies (breeding, health checks and surgeries). Collaborated, collected, analyzed and prepared results to be presented to committees/department heads for review.

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EDUCATION

Master of Science: Forensic Chemistry, 2009

Sam Houston State University - Huntsville, TX

Bachelor of Science: Biomedical Science, 2006

Texas A&M University - College Station, TX

CERTIFICATIONS

Six Sigma Green Belt

ASQ Certified Quality Engineer

Lead quality auditor ISO 9001:2015 certification

cGMP certification (Food Grade Substance, Kosher,

Food Contact Polymer)

REFERENCES

Available upon reques

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