David Haynie
Anna, Texas **409
Cell: 817.239.7513ASQ member# 65169091
e-mail: *************@*****.***
https://www.linkedin.com/in/david-haynie-6218784
Objective
A high-impact management position requiring creative and innovative approaches to problem solving, strategy development, and fulfillment of business goals.
The goal is to keep the product pipeline full of high potential, high volume products with important competitive advantages delivered to the market on time and on budget.
Summary of Qualifications
Strong math, English and computer skills including knowledge of spreadsheets.
Experienced in application of Continuous Improvement tools & techniques, i.e.; Kaizen, takt time, line balancing, focus factory implementation, process mapping, cause & effect analysis, cpK, SPC . . .
Oversee the quality system in a 97% Spanish-speaking environment.
Fluent in German, knowledge of Spanish.
A professional who has experience in analytically building and then executing new quality processes and Continuous Quality Improvement concepts that are fact-based and consumer oriented, while being sensitive to the needs of the channels.
Effective leader able to integrate myself into the team to learn from each team members perspective, so I can learn from each team members perspective, so I can do my best to put them in the best position to succeed, both individually and the team as a whole.
Proven QA leadership professional with prior industry experience and knowledge working in a cGMP environment, bringing experience from Nutraceuticals and consumer goods.
HACCP Manager & SQF Practitioner certificates.
69 semester hours at TCC toward a bachelors in Biology. President of Phi Theta Kappa.
3 years of experience in a QS environment, 5 years in an ISO-9001:1994 environment and
10 years of experience in a cGMP environment.
Obtained Halal and Kosher certifications.
Professional Experience
2013 – 2016Director of Regulatory Compliance / Contract Manufacturing Liaison
ProSupps USA, LLC Plano, Texas
Solid understanding of Import and Export Compliance rules and regulation, including, but not limited to the Export Administration Regulations and U.S. Customs Regulations.
Coordinated with Sales, Shipping, Customs Brokers and Freight Forwarders to ensure the company's global importations and exportations are conducted in accordance with the rules and regulatory requirements of Customs and other applicable governmental agencies in the affected country.
Was responsible for obtaining the required documentation for foreign regulatory submissions, import permits, health / Zoosanitary certificates, halal certification, etc.
Facilitated product qualification under the various Free Trade Agreements. Worked with applicable divisions and departments, external brokers, agents and attorneys to resolve internal compliance issues. Resolved clearance issues as required
ID verified for Level 2 access to USDA's AMS eDOCs.
Partnered with the Business Unit CFO, Director of Supply Chain, Product Category Managers, Accounts Receivable, Accounts Payable and Quality Assurance teams to confirm customer requirements, research discrepancies with project-based transactions, research like lots, and resolve contract-manufactured product reconciliation differences.
Conducted invoice reconciliation and invoice validation: matched CMO, vendor or service provider invoices with the agreed contract rates and the actual goods and services we received. Validated invoice details, matched invoiced amounts and verify contractually negotiated rates to reduce costs, mitigate fraud and improve compliance across the enterprise.
Consulted with product managers to review new products and make recommendations on material content to insure overall customs compliance.
Was responsible for obtaining cGMP Certificate of Free Sale (CFS) and Good Warehousing Practices (GWP), Certificate of Origin, as well as Food Manufacturers License and Warehouse Operator license from the TXSDHS.
2006 – 2013Quality Assurance/Regulatory Compliance Manager
DymatizeEnterprises, LLC Farmers Branch, Texas
Summary of Accomplishments
Developed an integrated Quality Assurance process and programs for the successful launch of new products in the context of the brand’s overall marketing efforts.
Helped the management team drive efficiency and continuous improvements to reduce non-value added costs, contributing to double-digit net sales growth (+20%/yr.) during an economic depression2009 2010 2011* projected 2015
Net Sales Growth: 20% 35% 36% 115%
EBITDA Growth: 110% 80% 30% 125%
* International sales are 41% of total Dymatize sales and growing
* International sales as a whole are up 34% YTD as of July 2011
While a portion of this growth came from process improvements to the core product lines, substantial growth came from new product innovation, staying ahead of the category.
As the QA Mgr., I acted as a subject matter expert for compliance and cGMP activities. Havea strong back ground in Kosher, FDA, USDA, EU USDA licensed, NSF certified, NSF for Sport certified facilities and foods-beverages manufacturing environments. This positionwas key in being a strong leader and provided change management and continuous improvement at every level.
Managed Compliance of the company, specifically: Quality Assurance, Customer Service & Sanitation
Helped to develop and audit the training performance of Quality Assurance and Quality Control staff; while building performance standards; scheduled and assigned work and develop priorities; provided technical expertise when needed or requested.
Fulfilled all functions of Director of Quality Services, in his absence
Worked with the Production Manager to train and evaluate the performance of Sanitation crew.
Worked very closely with Customer Service to maintain consumer interaction and expectations.
Built game plan for continuous improvement initiatives that drive value to the business, while simultaneously incorporating cGMP goals
Led and/or initiated collecting QCU key-performance-indicators (KPI’s)
Supported and maintained the laboratory, Q/A, and QC policies and procedures.
Prepared and maintained required documentation of test results; recorded and analyze data using computer hardware and software. This included equipment verification and calibration
Analyzed data to facilitate determining disposition of products, including raw materials and finished goods, against specifications
Interfaced with appropriate personnel for creation and/or updating of Product Specifications
Maintained a working knowledge of the latest codes and new developments in testing and examination methods of processes, materials, and products. Cleared inspection of raw material, in-process, and finished goods to meet specifications
Acted as key point-of-contact for cGMP audits (FDA, TX DSHS, NSF, and/or customer specific), and supported any regulatory activities (letters, responses, documents, follow-up, etc.)
Illustrated fact based decision making skills and was detail oriented
Determined disposition of non-conforming product and supported the execution of the disposition
Maintained Deviation Log and created reports that were meaningful to supporting departments for continuous improvement
Built a clear process flow for internal material/ingredient handling, process conditions & CCP’s, and internal audits to verify progress
Active in building & executing needed improvements identified by the FDA or internal audits
Audited the 3rd party co-packing companies and managed Kosher compliance.
Conducted auditing of batch records for finished goods release to help improve overall efficiency
Active member of product innovation discussions
Supported and was a creative member of the QCU leadership through excellent communication and team-building
Was responsible for the regulatory aspects of the company as it relates to the identity, strength, composition, quality, and purity of the product.