Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic
Luke Davison

Luke Davison

South Bend

Summary

Dedicated and knowledgeable Regulatory Affairs Specialist with over 15 years experience in Quality Assurance and Regulatory Affairs in the Food Manufacturing Industry. Has hit several milestones and achievements in the past 15 years with current employer. From playing a vital role in the creation and integration of the company's Tracegains program which involved the review and approval of over 20,000 regulatory documents, to the complete overhaul of the company's nutritional database for over 1,000 individual raw materials during the creation of a new Recipe Management/Product Specification System. Self-motivated and tireless in maintaining current understanding of legal regulations in order to keep all products compliant. Bringing many years of industry experience and seeking a growth-oriented position.

Overview

15
15
years of professional experience
5
5
Certification
4
4
years of post-secondary education

Work History

Regulatory Affairs Specialist

Zentis
Plymouth
08.2010 - Current
  • Current system administrator for document management, recipe management/specification systems, and all RA systems
  • Work with the FDA, as well as multiple state and city legislative agencies in Pennsylvania and Indiana, in order to register and acquire documentation for export.

o Health Certificate

o Certificate of Exportability / Certificate to a Foreign Nation

o Certificate of Free sale

o Documents for export Notarized and Apostilled through the Indiana Secretary of State

  • In the process of registering current employer with the FDA as a LACF producer
  • Completion of USMCA documentation for export to Canada and Mexico as well as accompanying RVC calculations to determine origination, tariff status, and HTS codes
  • Raw material document management and traceability of over 1,000 unique active raw materials
  • Specification creation and maintenance of roughly 400 active finished recipes, as well as customer required documents and relevant certifications
  • Regular contact with customers involving formulation, raw material information requests, nutrition, regulatory compliance, etc..
  • Certifications maintained with accompanying yearly audits

o Kosher – OU and KSS

o Organic –USDA certification through QAI

o Non-GMO –WFCF and FoodchainID

o Halal –IFANCA

o FDA registration

Quality Assurance

Zentis
Plymouth, Indiana
08.2010 - Current

Raw Material/Finished Goods Coordinator

  • Gave final approval and release from QA of raw materials to production, assuring that all raw materials used by production met all QA and regulatory standards
  • Gave final approval and release from QA of Finished product to the customer, assuring that all raw materials used by production met all QA and regulatory standards. and aligning release of finished product with demands of shipping schedules

QA Shift Supervisor

  • Oversee operation of the QA lab, as well as react to production issue.

Mobile Machine Operator / Quality Assurance

US Steel
Gary
11.2007 - 08.2010

Education

High School -

Oregon-Davis Jr/Sr High School
Hamlet, IN
08.2000 - 06.2004

Some College (No Degree) - Science/Radiography

Indiana University
South Bend

Skills

  • FDA regulations
  • Project management
  • Regulatory compliance
  • Document Management
  • Problem solving
  • Quality Management Systems
  • Time management

Certification

  • FDA Food Labeling Certificate – AIB
  • FSVP (Foreign Supplier Verification Program) – FSPCA
  • HACCP Certification – Purdue
  • USMCA Certificate – Global Training center
  • PCQI (Preventative Controls Qualified Individual) – FSPCA

Timeline

Regulatory Affairs Specialist

Zentis
08.2010 - Current

Quality Assurance

Zentis
08.2010 - Current

Mobile Machine Operator / Quality Assurance

US Steel
11.2007 - 08.2010

High School -

Oregon-Davis Jr/Sr High School
08.2000 - 06.2004

Some College (No Degree) - Science/Radiography

Indiana University
Luke Davison