Konrad Amo

Background

About Konrad Amo

Senior Quality Assurance Specialist with over 16 years of GMP experience across multiple departments including Quality Assurance, Quality Control (Microbiology/Environmental) and Manufacturing. Proficient in Quality Systems including Corrective and Preventative Action (CAPA), discrepancy management and change control. Experienced in managing and performing method validations to support new products and technologies. Experienced in project management, leading teams and managing employees as a front level supervisor. Led multiple cross-functional teams with clear focus, objectives and through strict adherence to timelines. B.S. in Biotechnology, emphasis in Microbiology.KEY SKILLS• Investigations, Deviation Reports, Out of Specifications (OOS), Trending, Excursions, Technical Writing• Microbiology Assays for In Process and Finished Product testing (Sterility, Stability, Bioburden, Endotoxin)• Method Development, Method Validation, Method Suitability Testing (MST), Adherence to Global Standards• Regulatory Audits, Internal Inspections (cGMP, Safety), Customer Audits, Supplier Audits, USP / EP / JP• Leadership, Management and Development of Employees, Presentations, Root Cause Analysis, Kaizen• Project Management, Implementation of new technologies in cGMP labs, adherence to current regulatory requirements, Equipment Qualification• Trackwise, SAP, Veeva, Filenet, Blue Mountain RAM, Laboratory Information Management System (LIMS), Endoscan