Alexis Creech

WORK HISTORY

EDUCATION

SKILLS

ABOUT ALEXIS CREECH

Experienced Quality Assurance Specialist with an exemplary record for delivering quality, regulatory, safety, and business guidance to ensure the delivery of quality products and services to customers while increasing the business’s profit and securing lifelong customers. With over 11 years in professional regulatory and compliance experience, I have developed continuously increasing analytical, problem solving, listening, and communication abilities making me a valuable resource to any team. TECHNICAL COMPETENCIESAuthoring, verifying and validating the following: Standard Operating Procedures (SOPs), Work Instructions, Supplier Quality Notifications, Internal Quality and Safety Alerts, Temporary Deviation Authorizations (TDAs), Audit Responses, EPA Biennial Report and Letter/ Memo to File for Regulatory bodies. Conducting Internal and Supplier Quality Audits, assisting with Regulatory, Customers, and ISO Certification audits, performing Root Cause Analysis, executing Corrective and Preventative Actions and performing Verification of Effectiveness Checks. Experienced in ISO 90••••08 & 2015), ISO 14•••••15), ISO 13•••••03 & 2016), FDA, NRC, EPA, OSHA, 10 CFR (Energy), 21 CFR (Food and Drugs), 29 CFR (Labor), 40 CFR (Environment Protection), 49 CFR (Transportation) and Global Harmonization. I possess a strong knowledge base in the tools and practices utilized in Six Sigma, Lean Manufacturing, Current Good Manufacturing Practice (cGMP), and the Toyota Production System to insure the proper design and control of high quality and efficient manufacturing processes. I possess certifications for OSHA 30 Hour and ASQ Quality Improvement Associate and currently working to obtain and/ or registered for certifications for ASQ Six Sigma & Lean Green Belt, Quality Auditor and Quality Process Analyst.