LUJEAN P. BURAK

*** ****** ****, *****, ***** Cell phone: 484-***-**** acscns@r.postjobfree.com

Quality Professional

Continuous improvement focused quality professional with experience implementing, maintaining, and continuously improving all aspects of quality programs for manufacturing facilities and corporate headquarters. Successful implementation of ISO 9001:2008, ISO 13485:2003, The American Chemistry Council’s Responsible Care® standard, and ISRS’s Modern Safety Management standard. Strong customer relationship skills developed while managing R&D Technical Service department and quality complaint management. Continuous Improvement expertise utilizing Lean principles, standard work, value stream mapping, visual management, Poke Yoke, Kanban, Kaizen, Six Sigma processes, 5S, SPC, DMAIC, DOE, RCCA, CAPA, DFMEA, and PFMEA. Knowledge of FDA regulations, GMPs and best industry practices. Process control and continuous improvement expert.

Core Competencies

ASQ CMQ/OE ASQ CQE ASQ CQA

ASQ Certified SSGB ISO 9001:2008 Implementation ISO 13485:2003 Implementation

Quality Management Quality Control Management Process Improvement

Document Management Customer Relationship Development CAPA and Root Cause Analysis

Safety Team Leadership Safety Program Development Safety Program Implementation

OSHA 30 Hour Compliance Training Security Expertise Responsible Care® Coordinator

Laboratory Testing and Analysis Business Development Technical Service

Cross Functional Team Development Chemical and Plastics processing FDA regulation expertise

Professional Experience

WESTLAKE PLASTICS COMPANY, Aston, PA (2014 – 2015)

Quality Manager – Managed ISO 9001:2008 and ISO 13485:2003 implementation, maintenance, and certification for medical device and industrial products for manufacturing site and corporate headquarters in a situation where re-certification was in danger. Responsibilities include customer complaints, root cause analysis, internal and external customer corrective action implementation and verification, and preventive action implementation and verification. Acted as the Lead Internal Auditor successfully developing and implementing the internal audit program including training materials, training, scheduling, audit report reviews, and CA implementation. Products include thermoplastic extruded rods, sheets, and films. Managed Safety Program and Document Control.

Managed ISO 9001:2008 and ISO 13485:2003 implementation, maintenance and certification for a manufacturing plant and headquarters implementing calibration programs, auditing programs, management reviews, quality awareness, and risk management which were lacking prior to my employment

No major non-conformances issued for either standard during external audits conducted by the ISO auditing body or customers as a result of improved calibration, auditing, management reviews, and CAPA systems

Managed the implementation of ISO 9001 and 13485 standards at a second manufacturing plant scheduled to be certified in 2016

Managed Final QC Inspection of all products including thermoplastic extruded rods, sheets, and films. Also responsible for final QC testing for compression molded sheets. Rejection rate significantly decreased as a result of inspection and procedural improvements

Managed continuous improvement efforts at both the plant and warehouse from receiving to shipping increasing on-time shipping rate especially for international shipments

Managed development and reporting of KPIs and implemented continuous improvement efforts to improve performance in manufacturing as well as business practices

Responsible for Medical Device certification review and First Article reviews for AS91000.

Improved the medical device certification process reducing the error rate to <1% from approximately 10%.

Responsible for calibration programs at 2 manufacturing locations. On-time calibrations went from <5% to 100% in a 3 month period.

Functioned as Lead internal auditor and developed the ISO 9001 and ISO 13485 audit program including materials and training

Developed a Risk Management Assessment program for all areas of business from raw material receipt to shipping

Responsible for complaint management including root cause analysis and CAPA implementation and verification

Significantly reduced complaint closure time (100 days decreased to 40 days) while putting improved CAPA systems in place

Developed a regulatory program where there previously was no program in place

Improved warehouse inventory storage resulting in decreased errors in product selection and decreased selection times

Developed a supplier evaluation and performance reporting program improving supplier quality and on-time delivery

CRAY VALLEY USA, LLC, (previously Sartomer Company) Exton, PA

Quality Manager; Responsible Care® Coordinator; Document and Training System Manager (2010-2014)

Implemented ISO 9001:2008 QMS and Responsible Care® MS standards at corporate headquarters and 6 manufacturing facilities in the US. Responsible for document issuing, distribution, training, tracking, and maintenance of new and revised documents including review and verification, reporting, training, revision control, and archiving.

Spearheaded ISO 9001:2008 certifications for corporate headquarters and 6 manufacturing sites including maintenance as well as continuous improvement efforts.

No major non-conformances found in either internal or external audits for any of the 7 locations

Implemented programs resulting in a significant reduction in the number of customer complaints relating to damaged packaging ( decreased by 50%) for international shipments for all product lines shipping from all 6 domestic manufacturing sites

Significantly improved customer response time for CA, PA, and root cause analysis with a goal of 30 days

Corporate and site RCMS® certification received 1 year in advance of requirements including corporate headquarters and manufacturing sites.

Managed development and reporting of KPIs and implemented continuous improvement efforts to improve performance in manufacturing as well as business practices

Successfully implemented the ACC’s Responsible Care® Security Code which is a requirement for RCMS certification

Participated on the internal auditing team, auditing all manufacturing sites during annual audits

Improved Product Development team efforts by initiating a program to include EH&S as well as regulatory considerations for relevant raw materials as well as final product

Manager, Technical Service; EH&S Support for Laboratories (1992-2010) Responsible for management of the Technical Service/Communications Group providing formulation and product recommendation to customers in coatings, inks, electronics, composites, and elastomers markets using acrylates, methacrylates, polybutadiene, styrene maleic anhydride, and metallic monomers. Responsible for literature creation and development for new and existing products. Expertise in new product introduction and sales monitoring. Expertise in UV coating formulating and technical service for UV applications. Responsible for removal of laboratory waste and safety program implementation.

Developed new business with potential customers as a result of formulations recommendations.

Developed new product use opportunities with existing customers as well as potential customers.

Developed technical literature (brochures, technical papers, technical data sheets, application bulletins), eliminating 90% of all printing and distribution costs for the company.

Laboratory Safety Committee member / lead responsible for monthly safety presentations, monthly safety inspections, corrective action implementation and review, PPE inventory, and quarterly waste removal efforts.

Laboratory Chemist (1989-1992)

Responsible for synthesis of acrylate oligomers based on acrylates, isocyanates and polyols. Responsible for application development working directly with customers to met their UV curable coating requirements. Worked directly with customers to determine their application needs and developed UV curable formulations to meet those requirements. (West Coast sales territory support). Safety team member.

Synthesized new oligomers to complete the acrylate oligomer product line so all molecular weights were available to customers

Developed UV curable coatings for pool balls, flexible packaging, metals, and various plastics

Developed various UV curable adhesives

LNP Engineering (Sabic), Malvern, PA

R&D Technician – Laboratory research and development as well as extrusion and injection molding scale up. Responsible for testing and characterization of thermoplastic composites. Test experience includes tensile, elongation, modulus, TGA, DSC, impact testing, HDT, and composition testing. Extrusion and injection molding experimentation and composite identification experience.

Education

Villanova University, Villanova, PA - Master of Business Administration

The Pennsylvania State University, University Park, PA - Bachelor of Science, Microbiology (Food Science emphasis)

Certificates

ASQ Certified Manager of Quality/Operational Excellence

ASQ Certified Quality Engineer

ASQ Certified Quality Auditor

ASQ Certified Six Sigma Green Belt

Skills

Proficient in Microsoft® Excel, PowerPoint, Access, Word, and Outlook, Reliance’s ETQ, QSI’s TMS, Adobe PageMaker, Adobe Acrobat, SalesForce, Minitab

Contact this candidate