Josh Aslinger

Background

About Josh Aslinger

Professional background and achievements include 3 years of Supplier Quality Management and Compliance, 6 years in ISO and GMP auditing, and 10 years in an Analytical Laboratory. Specifics: Education/Certification/Groups-Bachelor of Science (BS) in Chemistry from University of Tennessee at Chattanooga -Master of Science (MS) in Regulatory Affairs from University of Georgia -Graduate Thesis:"Adherence of cGMP for Atypical Actives for Use as Active Pharmaceutical Ingredients: A Survey of Industry"-Certified Auditor -Certified in Project Management through Sanofi's "End to End (e2e) Processes" Program -Former member of ASQ Professional Background (experience)-Supplier Quality Management including due diligence of new vendors, quality agreements, audits, product launch, performance data metrics -Certification of vendors to reduce redundant testing -Rx to OTC Switch -Quality Auditing for Major Pharmaceutical Companies -Aseptic and Non-sterile Manufacturing/Production/Laboratory Controls -Global Compliance for FCC, CE, ASTM testing standards -ISO 9001:2015 - Quality Management Systems -Label review (user manuals, carton packaging)-Good Manufacturing Practices for Pharmaceuticals 21 CFR 210/211 -Quality Systems for Medical Devices (21 CFR 820, ISO 13485)-CMO Supplier Quality -Analytical QC Lab Testing: USP/NF, HPLC, GC, FTIR, ICP, AA -USP Purified Water System Quality -Project Management: 1) Packaging Material Qualifications, 2) Supplier Quality Agreements, 3) Material Defect Identification and Reduction