HELEN B GERHARD **** Sodbuster Trail • Colorado Springs, CO 80917

C: 719-***-**** • H: 719-***-**** • fw23av@r.postjobfree.com

OVERVIEW

Core strengths: Technology Life Cycle Management • Quality Management, Engineering, and Audit • Problem Resolution • Training/Development • Logistics • Organizational Excellence

Quality Management and improvement experience focused in solutions partnering with internal and external customers. Strength in utilizing quality analysis techniques including statistical analysis, problem solving, and process mapping to develop fact based and process focused problem analysis and problem resolution.

Supply chain management from contract negotiations and proposal submission through sourcing, acquisition, delivery, warehousing, and strategic supplier partnering

Extensive audit experience including ISO 9001 and related standard specific to various industries (e.g. ISO13485 Medical Device Industry), Domestic and International standards and regulatory requirements (including safety, environmental, Sarbanes-Oxley (SOX), Baldrige criteria, and transport). See Training/Education section for additional information. Familiar with other industry specific standards (e.g. automotive, aerospace, other.)

Strategic change agent offering 10 plus years of progressive experience contributing effective solutions and continuous improvements to significantly enhance operational procedures and facilitate organizational excellence. Extensive experience with quality and business improvement tools (e.g. Six Sigma, Lean Manufacturing, Project Management, etc.)

Builds effective client relationships to identify requirements, meeting and surpassing expectations. Developed working relationships with partners throughout the world to meet their production, distribution, and regulatory requirement needs.

Guides cross-functional teams to achieve company goals within time and budget constraints. Combines quality assurance, technology, and industry knowledge to deliver consistent results in changing environments.

Understanding of budgeting and other financial request and reporting processes.

Commitment to exceptional Health, Safety, and Environmental (HSE) focus both internal and external customer expectations.

High level mastery of various Microsoft based software including MS Word, Excel, Access, Power Point, Outlook, Publisher, Project, Visio, etc. Experience in various systems and relational databases. Internet savvy in utilization of browsers, virtual team rooms, net meetings, and other.

Ability to travel extensively to domestic and/or international locations from local airport quickly and efficiently. Cost conscious to assure best value in regards to time and asset management.

Quality Assurance & Control/Process Improvement/Customer Service:

• Mapped a company’s procedures, authoring SOPs and work instructions for a quality manual in preparation for ISO 9001 and ISO13485 registrations. Registrar’s reported minimal non-conformances and observances in final report.

• Orchestrated and maintained a company’s quality system, including external vendor approval, Corrective and Preventive action (CAPA), Material Review Board (MRB), and product life inspections Incorporated related (i.e. safety and environmental) system requirements to create an aligned business management system, decrease liability risk, and avoiding fines.

• Prioritized outstanding action plans, realigning efforts to establish compliance with a prior audits. Completed initiative within 2 months, successfully enforcing existing plans and realigning ineffective procedures.

• Performed root cause analysis on recurring issues, producing CAPA plans and utilizing quality tools, including Pareto and other trending and Six Sigma methodologies to identify and permanently resolve them.

• Addressed customer complaints including investigation and interview of complainant, submission of MDR’s through MedWatch system, and documentation of corrective action plans to address mitigation and/or elimination of future issues.

• Developed and maintained in concert with manufacturing management and personnel various systems designed to produce product and services to stated requirements. Included using and training Lean/Six Sigma and other quality tools to achieve goals.

• Familiar with Quality Engineering concepts including metrology, gage and tolerance requirements, drawings, Failure analysis, and other techniques to assure product and services are maintained within stated requirements.

• Consolidated management review procedures, decreasing time frames from 1.5 days to 0.5 days while mitigating outstanding compliance issues and improving participant morale.

• Improved quality systems for several companies, identifying gaps and creating new procedures to enhance operational practices. Trained staff members in new processes and minimized litigation risk.

• Configured Oracle software to perform specific Dbase III requirements, enabling future information merge after contract closing and maintaining all required documentation.

• Worked closely with customers and internal organizations assure that customer requirements documented and understood. Managed customer complaint system to determine issues and to develop resolutions designed to protect customer relationship and company integrity

Operations/Contracts/Supply Chain & Materials Management:

• Developed production and shipping schedules in conjunction with contract manufacturers.

• Worked closely with financial personnel to assure that operations activities and financial forecasts & billing addressed.

• Performed as acting Director Operations for company to assure continuity with partners in areas of manufacturing, quality, and logistics.

• Researched product needs and made recommendations as to proper procurement strategy.

• Developed risk and mitigation plans to assure project and program objective met within time constraints.

• Selected, acquired, and integrated a medical device company’s laboratories and manufacturing divisions with the required equipment and instrumentation, cutting expenses 25%.

• Developed material handling procedures to assure inventory of raw components and finished product, integrated manufacturing processes, and assured development of test protocols to maintain product integrity.

• Implemented internal customs process to facilitate efficient material passage through multi-country customs systems.

• Assured that warehouse requirements meet resources of equipment, personnel, and software.

• Worked with R&D to develop BOMs to assure proper materials obtained for lean/just in time manufacturing processes

• Performed supplier audits to foster supplier/customer relationships.

Project Management/Training/& Presentation:

• Directed the development of a new CAPA system, conducting weekly meetings to maintain efforts within time constraints. Instituted virtual rooms and meetings to enable international interaction with project teams.

• Tapped to decrease warranty expenses, formulating new cost allocation procedures in compliance with legal regulations and CAPA guidelines to prevent future budget discrepancies.

• Trained new auditors, coordinated schedules, and worked closely with personnel to facilitate a complete quality system audit and improvements in compliance with ISO.

• Managed and supervised departments with multiple reports including hiring, couching, mentoring, reviews, discipline, and dismissal responsibilities.

• Excellent professional presentation skills utilizing various formats including one-on-one training, group presenations, and written courses.

• Responsible for developing, designing, and presenting a variety of topics to company personnel to meet departmental and companywide requirements. Included presenting quality system training (including cGMPs) and safety information to company personnel (including executive level). Ability to use computer both for personal use and for training others.

• Created forms and processes to track personal participation in training courses. Developed and maintained training matrix and personnel training files to assure compliance with Quality System.

CAREER OVERVIEW

HELEN B GERHARD, LLC Owner [2011-Present]: Provides project based services in the areas of quality management and auditing (including ISO9001and ISO13485), operations, logistics, technology management, business excellence, safety, and training. Extensive experience in Medical Devices and other FDA regulated areas as well as commercial construction projects, aerospace, education, gas pipeline, and general manufacturing. Adept in addressing global regulatory concerns.

CERAGENIX PHARMACEUTICALS, INC. Manager of Quality Assurance [2008- 2011] Acting Director of Operations [2009 – 2011] Acting Director of R&D [2010 – 2011]: Provides all Quality Assurance activities including review and release of product. Audits throughout the supply chain to assure compliance with all requirements. Provides oversight during validation activities. Saved company over $130,000 by proving raw material met production needs. Addressed customer complaints including submission of MDR’s through MedWatch system. Provides total regulatory support worldwide. Provides assistance with various partners. Since taking on operations duties, all scheduling for production and logistics support. Since taking on R&D duties, maintenance of all R&D activities and records.

A+ SERVICES Consultant [2005-2008]: Delivers quality, marketing, and administrative support to organizations within various industries, including medical devices and education. Contributes process mapping, Lean concepts, regulatory compliance, online quality systems and testing, and customer service improvements.

INGERSOLL RAND SECURITY AND SAFETY Customer Quality Manager [2003-2005]: Liaison between customer and internal departments, including quality and operations. 4 direct reports. Collaborated with customer service, technical support, marketing, and sales to mitigate customer issues. Evaluated warranty discrepancies, approved warranty expense payments to ensure proper data for claims processing, and integrated allocation systems to demonstrate ownership of product issues. Upgraded data collection software and directed CAPA system end-user training initiatives.

• Performed root cause analysis to identify and mitigate warranty trend issues.

• Revitalized a major client relationship by establishing and maintaining communication with the customer and providing cost-efficient product solutions.

EL PASO CORPORATION Gas Pipeline Scheduler [2001-2003] Supported customers for this gas pipeline operator, coordinating customer requests for natural gas flow in company pipelines with contract agreements and federal regulations. Addressed daily issues and inquiries, representing the company in client relations. Compiled and assessed data to deliver solutions to management. Ensured compliance with Federal Energy Regulatory Commission specifications. Forged collaborative relationships with internal and external clients.

US FILTER Quality Engineer [2000-2001] Instrumental in reconfiguring the ISO 9000 manual to ensure accurate deliverable equipment certifications. Coordinated auditing initiatives for quality systems maintenance. Represented the quality department on design teams.

• Audited the engineering department, delivering observations and findings and interfacing with the department to orchestrate corrective actions plans.

• Upgraded a company’s calibration and certification records, enabling all manufactured products to ship with required documents.

SYNTHES USA Quality Systems Information Engineer [2000] Enhanced the management review system. Conducted supplier audits. Collaborated with internal customers to identify and resolve issues. Participated in formulating an intranet-based CAPA system.

MEDLOGIC GLOBAL CORPORATION Quality/Safety/Environmental Specialist [1996-1999] Interfaced with R&D, marketing, sales, and operations to address concerns. Led 4 personnel, including document control and quality lab staff members. Integrated and managed quality, safety, and environmental systems for this medical device company to meet regulatory requirements. Conducted vendor audits. Addressed customer complaints including investigation of potential MDRs. Participated in developing test methods, sampling plans, equipment requirements, measurement techniques, and training guidelines. Worked closely with British counterparts to ensure consistency in quality products organization-wide.

EDUCATION/TRAINING

Graduate Certificate in Government Contracting, Webster University

MBA in Technology Management, University of Phoenix • BS in Chemistry, University of Colorado

IRCA Certified ISO9001:2000 40 Hour Lead Auditor Training

ASQ Certifications: Quality Management/Operational Excellence • Quality Auditor • Quality Improvement Associate

Professional Development: Ingersoll-Rand and American Chemical Society Leadership Training Program • Conflict Management • Coaching Skill for Managers • Safety Training • Active in professional societies (i.e. American Society for Quality, American Chemical Society, Rocky Mountain Regulatory Affairs Society)

Contact this candidate