This document is a resume for Michael "Kellie" White that outlines their professional experience and qualifications. White has over 15 years of experience in quality assurance and regulatory compliance roles in the biomedical and pharmaceutical industries. They have extensive knowledge of quality system standards and FDA regulations. Their experience includes managing quality systems, auditing, developing standard operating procedures, and ensuring compliance. Currently, White works as a Compliance Auditor at CryoLife, where they assist with quality management systems, auditing programs, and ensuring regulatory compliance.

1. MICHAEL “KELLIE” WHITE
mkbolling@gmail.com
5080 Brownwood Drive
Powder Springs, GA 30127
770-402-2311
LinkedIn Profile: https://www.linkedin.com/pub/michael-kellie-white/6b/165/461
SKILLS:
• Microsoft Office
• Oral & Written Communication
• Management & prioritization of multiple projects
• Knowledgeable in ISO 13485, ISO 9001, 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 1270,
21 CFR 1271, American Association for Tissue Banking Standards, Current Good Manufacturing
Practices, Current Good Laboratory Practices, Current Good Tissue Practices and Current Good
Clinical Practices
• Experienced author of quality system documentation including quality manuals, corporate policies
and standard operating procedures
CERTIFICATIONS
• Certified Quality Auditor (American Society for Quality)
WORK EXPERIENCE:
CryoLife, Inc. Kennesaw, GA November 2008 – July 2015
Compliance Auditor
• Assist Management with development and implementation of policies, procedures and practices
related to Quality Management System, ISO Standards, FDA Regulations, and other applicable
industry standards
• Experience participating in FDA, ISO, AATB, State Agencies, International Regulators and
Customers compliance audits
• Assisting in the management of the Internal Audit Program and the Recovery Partner Audit
Program
o Maintaining annual audit schedules and electronic audit database
o Review and report audit findings in a timely manner
o Collect and analyze audit data to identify negative trends
o Ensure nonconformance’s identified during an audit are appropriately addressed in a
timely manner
• Serve as Lead Auditor for Internal Audits, Recovery Partner Audits, Supplier Quality Audits and
Contract Research Organization (CRO) Audits
• Assist in the management of the Corrective/Preventive Action (CAPA) Program
o Maintain completed Corrective/Preventive Action Requests
o Quarterly Reporting of program performance and noted trends
o Assist CAPA owners with root cause investigations
• Assist in the management of the Laboratory Compliance Program
o Perform desktop audits of laboratories
o Maintain Laboratory Compliance Files and associated electronic database
• Lead and participated in Process Improvement Initiatives
• Assisted with the hiring, training and mentoring of new employees
• Present Quality Training segment of New Employee Orientation
Diversified Healthcare Services, Inc. Roswell, GA February 2007 - September 2008
Quality Control/ Regulatory Supervisor
• Performed Departmental Audits
• Performed Departmental Training
• Conducted In-Process and End-of-line Checks on all products
• Documented and Updated Standard Operating Procedures
• Conducted New Employee Training and Employee Continuing Education Training

2. o Good Manufacturing Practices Guidelines
• Implemented and regulated Government Regulations, e.g. FDA and DEA regulations
• Investigated all customer complaints and document resolution(s)
• Reviewed internal errors for trends and implement procedures to correct them
• Registered pharmaceutical products with the FDA
• Reported usage of Schedule 2 and specified Schedule 3 pharmaceuticals to the ARCOS unit of
the DEA
Allstate Technical Services Dalton, GA February 2006 – February 2007
Laboratory Technician
• Assisted Researchers in developmental testing
• Maintained inventory and carpet supply
• Performed End-use testing and evaluations and Combustion Analysis
• Maintained laboratory safety procedures
Deerland Enzymes Kennesaw, GA May 2004 – February 2006
Quality Control Technician
• Performed quality assurance assays on products
o Microbial Testing
o Food Chemical Codex (FCC) Regulated Testing
• Developed new products and assays
• Performed quality assurance checks on products during the production phase
• Composed Certificates of Analysis for products manufactured and tested
• Received and resolved customer complaints
EDUCATION:
LaGrange College LaGrange, GA May 2004
Bachelor of Arts in Biochemistry, minor in Biology