Hermanda Williamson

Quality Assurance Manager

McDonald, TN

acqrv7@r.postjobfree.com - 336-***-****

Quality Assurance (QA) Professional with 16 years of experience with high-growth and established manufacturers of medical devices, personal healthcare products, and corrugated packaging. Broad background ranges from QC/QA analytical testing to technical/management roles. Display unwavering passion for providing customers with the best service and products possible while supporting company strategy and continuous improvement. Successful record of building Quality into business processes, supporting efficiency through Six Sigma/Kaizen/Lean concepts, and supporting technological advancement. Exhibits solid presentation and verbal/written communication skills. Technically proficient with MS Office applications and SAP. Core competencies include:

ISO 13485/FDA 21 CFR Part 820 Regulations GMP Team Leadership Project Management Business/ Operations Analysis Training Development Performance Measurement SPC/Minitab MS Office Applications SAP

WORK EXPERIENCE

Account Install Sr. Associate

Cigna Healthcare - Chattanooga, TN - September 2014 to Present Responsibilities

Responsible for timely and accurate generation of customer invoices and/or billing system structure builds.

Accountable for end to end oversight of a dedicated book of business in order to ensure billing completion within required turnaround time.

Ensure accurate and timely communication to customers, clients, internal partners such as Revenue Account Specialists and Global Service Partners to ensure clarity in all correspondence.

Serve as a subject matter process and technical expert to matrix and global service partners.

Utilize and correctly update appropriate tracking tools to ensure ownership and progress of work items and issue resolution

Take initiative to identify process improvements and implement them as needed.

Support and assist in the successful completion of team goals and other tasks as assigned.

Prepare monthly and other requested ad hoc reporting as needed. Quality Assurance Manager

WNA, Inc. - Chattanooga, TN

Responsibilities

Responsible for managing six QA inspecrors, providing training, and setting daily direction of quality department task. Has completed oversite of the Quality System across three manufacturing plants and two warehouses which includes customer complaint resolution, handling returned goods, nonconformace resolution, internal/external audits, deviation management, procedure reviews/revisions, first article qualification, and specification development/approval. Perform trend analysis and reports in support of the Quality System. Also has oversite of the plant Food Safety program. Accomplishments

Developed spreadshewt tools to ensure proper trend analysis. Implemented a formal quality traing program . Quality Manager

Georgia-Pacific - Ridgeway, VA - 2013 to 2014

Oversaw all aspects of site-wide quality system, including accountability for driving continuous improvement, customer issue resolution, documentation/records management, and product risk assessment. Administered and participated in site’s quality audit programs and Statistical Process Controls (SPC). Assessed process and procedural changes for risk to product quality and compliance with company standards. Provided input for annual budget and resource plan.

• Responsible for site implementation of Safe Quality Food (SQF) certification which involved leading the development of the site HACCP plan, Business Continuity plan, Product Defense plan, internal standard operating procedures (SOP) and document control process, training plan, audit plan, SQF metrics, and providing plant-wide training on these processes.

• Managed Product Stewardship program to ensure product safety throughout the supply chain.

• Served as a member of the site Leadership team and produced monthly business reports. QA Systems Business Analyst

Becton, Dickinson and Company - Burlington, NC - 2010 to 2013 Directed implementation of SAP ERP system for manufacturing quality functions. As project leader, oversaw project development/management, hiring and supervision of external resources, issue resolution, and status reporting. Offered input for annual budget and resource plan. Identified storage locations and data configurations alongside warehouse management. Worked cross-functionally with procurement and purchasing to define material receipt master data; partnered with manufacturing operations and document control group to manage product master data and document definitions.

• Headed site Change Control process used to analyze and document all product and document changes relevant to ensuring intended use of product by customers; maintained ISO and FDA compliance.

• Assisted with establishing department goals, setting performance measures, and delivering results for quarterly business review.

• Championed efforts to gather internal customer requirements, identify most optimal data configuration, and increase productivity via procedural changes and transfer to paperless environment.

• Improved change assessment tool to provide a more robust method of identifying risks, costs, and required actions during new product development or product changes; reduced post-implementation errors 25%.

• Received "Big Hit" award for contributions to closing and reducing open Corrective and Preventive Action

(CAPA) projects.

QA Associate II

Becton, Dickinson and Company - Burlington, NC - 2009 to 2010 Steered daily direction of six QA inspectors. Responsible for MRB process and daily production records review for regulatory/GMP compliance in support of product release. Performed SPC metric /trend analysis of product/ process defects, and proposed resolutions. Completed internal audits and led manufacturing group in ISO/ FDA regulations and GMP best practices. Participated in investigations and CAPAs as needed.

• Created and streamlined standard procedures while maintaining a product release accuracy rate of 99%.

• Supported continuous improvement efforts by providing documentation training to manufacturing, resulting in a 26% increase in Right-the-First-Time metrics. Led efforts to revise and improve the Deviation and Rework procedures/records, and participated on a team to improve the Nonconforming product procedures/records.

• Redefined raw material specifications and instructed batch production process changes reducing nonconformance monthly total averages from 45 to 28 per month over a six month period. QA Laboratory Team Leader

Procter and Gamble - Browns Summit, NC - 2009 to 2009 Set daily direction for 11 laboratory personnel, including training/growth of direct reports. Investigated product nonconformities and dispositioned product. Performed and monitored equipment calibration and maintenance.

• Implement and maintain Lean concepts/practices (6S, Standard Work, Visual Controls, Value Stream Maps)

• Managed efforts to cross-train 18 laboratory personnel, increasing percentage trained from 35% to 85% in six months.

• Maintained Blue Mountain laboratory equipment calibration/maintenance database and program to ensure work order completion rate of 100% on time.

Quality Assurance Compliance Associate

Procter and Gamble - Browns Summit, NC - 2005 to 2009 Primary responsibility for SOP Document Control and Annual Product Review processes; involved product trend analysis, capturing opportunities for improvement, and recommending solutions. Scheduled and conducted internal /external audits. Participated in planning annual budgets/resources and setting department goals.

• Owned product stability program, ensuring the completion of testing protocols designed to establish and confirm product shelf life; transferred stability program from access database to SAP system.

• Oversaw and participated in Kaizen events to implement 6S, Pull Systems, and Standardized Work procedures; included increasing finished product testing productivity 30% and leading a collaborative team to reduce raw material release time from 3 days to 2 days by eliminating non-value added work.

• Support SMED activities as the Kaizen team Quality SME and document change reviewer.

• Supported implementation of TrackWise database system utilized for documentation of CAPAs and audits. QA Laboratory Analyst

Procter and Gamble - Browns Summit, NC - 1997 to 2005 Conducted analytical testing of raw materials and finished goods according to USP methods (i.e. HP GC/ LC/IC, FTIR, AA, pH, Viscosity, Sensory) in support of product investigations/release, stability protocols, and validations.

EDUCATION

BS in Industrial Technology Management

East Carolina University - Greenville, NC

AAS in Computer Information Systems

Guilford Technical Community College - Jamestown, NC LINKS

http://www.linkedin.com/in/hermandawilliamson/

CERTIFICATIONS

Certified Associate in Project Management PROJECT MANAGEMENT INSTITUTE

(PMI)

Business Analysis - Completed SDLC Program with ASPE, INC

Contact this candidate