1. GAY LEE ALVIS
2720 Gatewood Circle, Charlottesville, VA | (434) 964-7113 | gleealvis@gmail.com
QUALITY MANAGEMENT PROFESSIONAL
Dynamic Quality Management Professional with deep-rooted experience and a proven track record of success and dedication to
executing continuous improvements and modifications in multiple manufacturing industries including Plastics PET, Automotive,
Aerospace, Marine Propulsion, Packaging (Food grade; SQF Level 2 & Level 3 Attainment) and Pharmaceutical (Class II & III), Medical
Device (Class I,II, & III) & Consumer Products. An expert with invaluable knowledge of managing projects, resources and systems in an
efficient and effective manner. Keen ability to quickly problem-solve issues and apply an effective solution. Highly focused and adept at
consistently employing best business practices to improve the overall performance, and simultaneously reducing costs. A valued leader
and contributor who has the ability to build and maintain positive relationships (internally and externally), along with successfully
working as a team member (as well as independently). Seeking a challenging position with a forward-thinking organization.
CORE COMPETENCIES
ASQ Quality Auditor, (CQA); Supplier Quality Engineer Performance Optimization
ASQ Certified Quality Engineer (CQE); ISO 9001:2008 & 2015 Global Exemplar Certified Lead Auditor
Certified Food Defense Coordinator (A.I.B.I.), Certified Advanced SQF Practioner; HACCP, HARPC
Kaizen, Lean Manufacturing, Poke-Yokes; ASQ Certified Green Belt (CSSGB), experienced in 5S Instruction
8D Problem Solving Quality Improvement Teams (QIT) APQP PPAP Submissions; Six Sigma
Quality Management System Development; Strategic Quality Planning
Canada, Mexico, and various countries point of contact, registration development
DMAIC Quality Management System Implementation; cGMPs; 21CFR810
Performance Based Continuous Improvement; 13485 Standard Compliance
Hazard Analysis Critical Control Point (HACCP) CAPA;GDT;SPC; Corrective Action Requests (SCAR & CARs & CAPAs)
Advanced Product Quality Planning (APQP)
FDA point of contact, ANDA and trademark registration
ASQ Certified Quality Manager / Organizational Excellence (CMQ/OE)
PROFESSIONAL EXPERIENCE
Phoenix Packaging, Dublin VA May 2016 – Feb. 2017
Quality Manager; - Quality Compliance Manager
• Managing production inspection, 20 lab personnel, over quality systems supplying food customers such as Danone, Keurig
and General Mills. Direct Customer contact, in addition to working with R&D & various other issues relating to quality
throughout the company.
• Providing training, development of employees for increased quality and productivity. Material Review Board Team Leader,
driving prompt determination of Nonconforming Material Review, Status & Disposition. Took lateral move to Quality
Compliance Manager in September, after SQF practioner leaving.
• Quality Compliance Manager – September through February
• Managed Quality Systems development for SQF, IMS, FDA compliance; backup Quality Manager while acting Quality
Manager out at customer locations, vacations, and various other reasons & duties. On call 24-7.
• Taught cGMPS, Haccp, Harpc, Food Defense, Risk Management and various other areas as necessary.
• Lead Crisis Management team through drills, developing food defense audits, systems, and manual including Food Quality
Plan and Audit plan.
• Lead Audit teams and certification team for Manual development, systems compliance and enabling facility to achieve level 3
certification of SQF in January. (Cert ID registrar). Downsized after 2017 budget review with reduction in customer sales
(Keurig) and company restructuring.
HOLLISTER, INC., Stuarts Draft, VA April 2013 – Feb. 2016
Senior Quality Engineer - Contract
Apply leadership and expertise in contract plant manufacturing, new product development and technical services development
quality engineer, plant overflow quality engineer support.
Provide support in the BIM (injection molding) area, Mix area, and multiple protocols throughout the plant.
QA Proficiencies &
Management
Read/Translate Blue Prints
Test Planning & Tracking
Project Analysis & Metrics
Risk Analysis
Defect Management
Project Management
Performance Management
Superior Leadership Skills
Staff Training, Coaching &
Mentoring
SQF Level 3 Attainment
SPC, GD&T
Communication
(Internal/External)
Customer Satisfaction
Strategic Planning
Executive Communications
Team training, Auditing training
Systems Auditing, Development

2. GAY ALVIS, RESUME – PAGE 2
Execute the process capability studies, development of Feasibility, Validation, DOEs, IQ, OQ, and PQ and Double Blind
Studies protocols, execution of protocols, data analysis on various studies, process improvement studies, document
investigations, assisting Japan task force team in new release liners by studying air bubble reductions (leading a mix team).
Facilitate data analysis on protocol evaluation, support quality engineers on work overflow, Supplier teams, protocol
development of equipment moves, and additional duties as assigned.
Successfully reduced air bubbles, foam, defective vacuum batches from 50% to 2% out of 444 batches, resulting in increased
throughput and reduced defects and enhancing customer satisfaction for Japan customers.
CONTINENTAL CORP., Culpeper, VA April 2012 – May 2013
Quality Engineer Weekend Supervisor, Service Quality Engineer, Weekend Supervisor for Service Production Line
Led in quality and production shipping metrics service value stream and conducting internal audits and business processes.
Examined supplier ratings, performed Supplier Corrective Action Request development (SCARs & CARs), supplier PPAP
requests, reviews, APQP and completed other supplier quality measurements.
Developed, wrote and approved Standard Operating Procedures (SOPs) and Work Element Instructions (WES) for TS 16949
manual, in addition to collaborating with various teams ensuring the validation of new production lines and conducted
production PPAPs of all service production lines for startup in Culpeper.
Developed and documented packaging instructions for operators, audited outgoing shipments, conducted weekly review of
Safe-launch audit reports, trained operators and leads on new processes, which included the new production lines for brake
production, webbing, peening, caliper building, etc.
MICROAIRE SURGICAL INSTRUMENTS, Charlottesville, VA May 2011 – April 2012
Quality Engineer and Internal Auditor (Internal/External)
Maintained full charge and responsibility for Quality of operational stream of a power motors and instruments (pneumatic and
electrical) manufacturer.
Expertly conducted internal audits (as part of the monthly internal auditing team) for all business processes.
Analyzed supplier ratings, performed supplier Corrective Action Request development (CAPAs), and completed other supplier
quality measurements.
Developed, wrote and approved Standard Operating Procedures (SOPs) for 13485 manual, and collaborated with various
teams to develop New Product Development.
Audited and worked with suppliers to reduce receiving quality issues, reducing CAPAs, lead Pneumatic Motor team which
increased First Time Yields from 45% to between 97% to 100%, and reduced Warranty Repair percentage rate from 68% to
29%. Effectively reduced Scrap Rate from $2,000 to $200 per month for power stream.
STARPET, INC., Asheboro, NC July 2008 – Feb 2011
Quality Auditor (Internal/External), Quality Engineer, for Plastics PET manufacturer
Provided leadership and management of ISO development and audit program for a PET Resin manufacturer (internally and
external). Direct contact with FDA, customers, wrote submissions for ANDA and trademark submission.
Conducted audits of business processes, suppliers, and laboratory processes.
Reviewed supplier ratings, performed supplier Corrective Action Request development, and completed other supplier quality
measurements.
Approved all Standard Operating Procedures (SOPs) for ISO 9001:2008 Standard (compliant with AIBI, ISO 22000,
pharmaceutical class III resins and toy grade resin), as well as work with various teams (including laboratory) to complete work
instructions and other procedures.
Created and wrote QSM and QSOPs for the Quality Department (GLPs, cGMPs).
Automated laboratory reducing necessity for adding laboratory personnel and enhancing COA submission capability & traceability.
Other Professional Experience:
D&D Enterprises, Randleman, NC
Quality Manager, Total Quality Manager, 2006 – 2008
Rymac Enterprises (a division of Q3JMC, Inc.), High Point, NC
Quality Manger, 2004 – 2005
A.O. Smith, Mebane, NC
Quality Engineer, 2000 - 2001
B.T.R., Reidsville, NC
Quality Engineer – BMW and Ford Accounts, 1999 – 2000
John Harland Company, Greensboro, NC
Quality Director, 1998 - 1999
Owens-Illinois, Plastic Division, Perrysburg, OH
Divisional Quality Engineer, 1994 - 1998
Graham Packaging, Maryland Heights, MO
Quality Manager, 1992 – 1994
ADDITIONAL PROFESSIONAL CERTIFICATIONS / MEMBERSHIPS
Graduate Coursework towards, MME, Jacksonville University, Jacksonville, Florida
Bachelor of Arts, Physics, Miami University, Oxford, OH; Member: Miami Alumni Association, ASQ, ASTM, ACS, SARA
Certified High School & Middle School Math, Chemistry & Physics Teacher, State of Florida