Six Sigma Manager

Yanaliz Whelan

Quality Manager, Six Sigma Black Belt Certified

Elizabethtown, KY 42701

*******@*****.*** - 270-***-****

As Quality Manager and Six Sigma Black Belt I’m enjoying the opportunity of networking with professional people in Scientific, Pharmaceuticals, Healthcare and/or Automovile/Manufacturing fields. My vision is to improve my professional experience, scientific, problem solving (Lean/SS), analytical skills, auditing skills: reviewing standards and regulatory compliances, technical experience and education. I can balance the following: Strategic thinking (long term); Creative (can make linkages that are not obvious); Analytical (looks for facts, data, and evidence). I am able to work well under pressure and able to effectively accommodate competing priorities. I know how to organize large amounts of information and how to manage the progress of assigned programs. I have an excellent communication and interpersonal skills. Authorized to work in the US for any employer

WORK EXPERIENCE

Quality Assurance Manager

CVS Health - Louisville, KY - 2016-05 - Present

Overview: The Brand Support Services (BSS) Quality Manager is responsible for coordinating quality assurance activities, validating processes, maintaining documentation supporting program performance, and responding to audit requests; both internal and client requested. As a member of the leadership team for the Brand Support division, the Quality Manager manages all the quality internal audits and utilizes professional conduct when interfacing with staff and clients. The Quality Manager provides assistance to the Management Team in areas of reporting of HIPAA Violations, quality monitoring and auditing, program and system documentation review and approval and verifies training, client interaction on processes, program performance, and feedback on staff performance.

•Review all new business proposals, including changes to the scope of service for existing engagements, to evaluate business quality requirements and ensure that operational plans are developed and implemented for each new program implementation.

•Coordinate, train, and direct Operations Program Management personnel on established QA activities

•Establishes and maintains the Standard Operating Procedures (SOP) control system to ensure compliance to organizational requirements. Collaborates with other members of management to ensure all processes within Brand Support Services are documented and following approved SOP and ISO guidelines.

•In conjunction with Operations Program Management, establishes baseline productivity standards for individual program staff members by title/function aligned with approved staff and pricing model.

•Enforces quality policy through investigation of key performance indicator non-performance, analysis of customer complaints, and maintenance of an internal audit process.

•Performs program reviews to ensure contractual obligations are being met and reports findings to Senior Leadership.

•Work with client audit teams ensure that information is provided timely and responses are managed effectively.

•Make recommendation for and lead continuous improvement projects in the healthcare settings.

•Complete monthly audits of Patient Triage, Pharmacy and Medical coverage (commercial, VA or Medicaid/ Medicare) determinations for all clients and programs. Plant Improvement Manager, Dedicated Black Belt

Dynacraft, a PACCAR Company - 2013-03 - 2016-02

Overview: Managed Divisional Projects and contributed to meet the Goal of $4.6M YE total savings. Collaborating with leadership to develop a division continuous improvement roadmap, driving the business for the best performance with either: 5S Evaluation, Kaizen Events, Just Do It improvements, Six Sigma projects, DFSS or Lean Implementation projects. Fact based decision making. Manage and work with improvement projects of all types in various areas of Dynacraft and PACCAR Company. Approve project ideas, scope the business opportunity, help/coach/mentor others on their improvement projects as well. As the Six Sigma Program Administrator, activities for the managing, monitoring and updating the Division Project Tracking tools are completed. In addition, the reporting of the Six Sigma Program Monthly and Annualized Savings are completed and reported to the Corporate Headquarters in Bellevue, WA.

• Applying advanced Lean and DMAIC tools to improve product and process design throughout the company booking over $1.4M in savings (2015 YE)

• Transfer best practices, techniques, procedures and tools to peers and other process improvement teams

• Work with cross-functional teams to implement productivity improvement, on 2015 we measured 38% productivity increase across the Plant

• Provide analysis (cpk, time study, PPAP data review) and feedback to senior management on project activities, improvements, and savings

• Develop and lead Lean and DMAIC training classes

• Demonstrate successful application of new methodologies to improve product and process quality

• Review/critique projects for proper methodology and tool usage

• Supervising a Lean Belt - PPS Coordinator that reports directly under my position

• Managing the Six Sigma SharePoint Site, Project Tracking Tool and Savings (hard and soft savings), balance the savings summary for each project and report the monthly and annualized savings to Corporate Office

• Providing technical and strategic leadership in meeting Operational Excellence goals and objectives

• Defining and implementing process improvements on key initiatives that result in significant improvements in service delivery, increasing organizational effectiveness, increasing the safety of our environment to those providing and receiving services

• Delivering clear and concise communications, meetings, presentations and/or recommendations to staff, management, executives, and peers within the organization

• Consulting with senior leaders to identify potential Operational Excellence (OE) projects and develop project proposals

• Developing, approving projects and project timelines.

• Lead, train, coach and guide team members through completion of each project

• Ensuring the Plant's key metrics (PPM, OTS, DR, Safety, etc.) are defined, developed, tracked and re- evaluated in each project; and that improvements result in a positive impact for each project Quality Assurance Associate II

American Red Cross - Louisville, KY - 2007-07 - 2013-03

• Conducted monthly Internal Quality Assurance audits per cGMP (Current Good Manufacturing Practices), Red Cross policy, FDA and AABB regulations

• Conducted investigations regarding any Hospital Concerns or Complaints due to any blood transfused product

• Assisted Quality Director and operations management in preparing for, hosting and closing out FDA, AABB, Red Cross, CLIA, or other inspections as necessary

• Maintained and updated FDA, AABB, CLIA regulated documentation of accreditations

• Monitored and audited the implementation and effectiveness of corrective actions plans for product and process

• Identified and communicated concerns in the collection, hospital areas, manufacturing and testing process to Quality Assurance and operations management staff to ensure that compromised product or test results are not released, and immediately implementing procedures for recall or market withdrawal if deemed necessary

• Conducted investigations and performed in-depth analysis to identify trends, risks, and systemic problems and developing corrective actions and effectiveness checks which was included in the facility monthly summary report for the region

Lean Enterprise, change management

American Red Cross - Louisville, KY - 2006-01 - 2007-07 Louisville, KY January 2006- July 2007

Lean Six Sigma Black Belt II

• Led Donor Process Flow and Donor Deferral Rates Improvement projects bringing over $1 million in savings, and led Cycle and Quarantine Time Reduction projects

• Completed and closed a total of four Six Sigma projects and one closed project under group collaboration

• Conducted several Kaizen Event / Blitz for small scale manufacturing improvements

• Facilitated project teams to efficiently and effectively employ methodologies and tools including six- sigma (DMAIC: Define-Measure-Analyze-Improve-Control) and (DFSS/DMADV: Design for Six Sigma/ Define- Measure-Analyze-Design-Verify), Lean Enterprise, change management, etc.

• Maintained the integrity of the Six Sigma measurements, improvements and tollgate reviews

• Used Continuous Improvement tools such as CTQ, FMEA, SIPOC, Cause and Effect Analysis, System Performance Analyze, etc. to help Compliance Improvement Teams reach their goals

• Successfully led large cross functional teams to accomplish significant process improvements goals such as sustaining standard work

• Developed and was responsible for the Regional Project Hopper. This prioritization tool was created to help prioritize, select, and charter high-impact Lean Six Sigma projects

• Applied Kaizen Events to drive solutions that prevented opportunities for defects

• Mentored, trainered, and coached Six Sigma practicioners

• Developed, maintained, revised and provided Lean and Six Sigma training materials

• Trained Lean Manufacturing and Six Sigma principles to all levels of the organization Process Control Specialist

American Red Cross - Louisville, KY - 2004-08 - 2004-08

• Worked and participated in developing "in services" training to implement, review and monitor all critical points of systems and processes as specified in the operational procedure

• Notified upper management of potential regulatory/compliance issues identified through data analysis

• Conducted investigations and performed in-depth analysis to identify trends, risks, and systemic problems, and developed corrective actions and effectiveness checks which were included in the facility monthly summary report for the region

• Participated in development of effectiveness checks, collected and reviewed quality data to monitor effectiveness of corrective actions

Scientist II

Abbott Diagnostic Laboratories - Barceloneta, PR, US - 2001-06 - 2004-07

• Served as a lead scientist, team leader and individual contributor, and interacted with various personnel at all levels

• Supported in the formulation and scientific developement of fertilty and pregnacy testing

• Utilized advanced scientific analysis and troubleshooting skills for product development and improvement

• Conducted investigations, processed CAPA, complaints and wrote reports of the daily operating activities with potential impact to product quality

• Validated manufacturing equipment, process, laboratory equipment and methods

• Supervising four Lab Technicians that reports directly under my position

• Worked with cGMP and FDA regulations

• Led various projects and was responsible for implementation, characterization, validation, regulatory files, regulatory inspections, compliance, auditing, issue resolution, evaluation of complaints and team / management updates

EDUCATION

Masters in Agricultural Sciences

University of Puerto Rico

2001

Bachelor in Biology

University of Puerto Rico

1998

SKILLS

Master Black Belt, Six Sigma Black Belt, Six Sigma Green Belt, Pharmacy Technician, Agile, Lean Manufacturing, Lean Six Sigma, Leadership Development, FDA Regulations, Quality Management, Quality Assurance, Statistical Process Control, Statistical Analysis CERTIFICATIONS/LICENSES

Pharmacy Technician, Kentucky Board of Pharmacy

2017-03 - 2018-03

Knowledge critical to pharmacy technician practice organized into nine knowledge domains. ADDITIONAL INFORMATION

Skills

• Bilingual language skills: English-Spanish written and spoken

• Ability of establish and maintain effective working relationships with staff at all levels

• Proven project management skills, strong quantitative and problem solving skills

• Proficient in Microsoft Office 2010 programs: Word, Microsoft Project Management, PowerPoint, Access, Visio 2010, Excel, Excel-QI MACROS, SharePoint Site

• Extensive knowledge of Minitab 17, Quality Companion 2-Minitab, and SAS (statistics)

• Experience with SmartCAPA, Business Objects WebIntelligence, Data Warehouse, BI-SAP Crystal Reports, KRONOS ShopTrac Viewer and Windows SharePoint Admin Core Competencies

• Project Planning and Execution

• Team Leading and Mentoring

• Quality Assurance Standards

• Global and Corporate, Collaborative Communication

• Qualification Plans and Reports

• Plastic, Metal Mfg. Process Expert

• Proven Tracking Project Record

• FMEA (Process / Design)

• 8D Corrective Action Report

• Continuous Improvement Focused

• Capital Budget Projects

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