Richard Bartkowski

About Richard Bartkowski

Quality professional in the pharmaceutical, biotechnology, and immunotherapy industry with extensive experience in quality control, quality assurance, quality systems, staff development, project management and analytical development. Specialties: 1. Development and quality control of small molecules, proteins, and cells through clinical trails to commercialization.2. Quality systems such as change control, deviations, OOS investigations, audits, and CAPA3. Management and development of supervisors, laboratory professionals, and quality specialists4. Environmental monitoring, microbial libraries, disinfectant studies, and cleaning validation5. Lab computer systems, data integrity, and instrument validation

Experience

1. Associate Director, Quality Assurance

   Kite Pharma

   Mar 2022 — Present

   Developed, implemented, and maintained quality systems such as change control, deviations, CAPA and supplier qualificationDeveloped and managed a documentation management groupConducted internal audits to ensure quality and compliance for the following departments: manufacturing, material management, facilities, quality engineering, quality control, and supply/sourcingConducted external supplier audits to support the supplier qualification programProvided quality assurance review of quality procedures, analytical methods, and final product/raw material specificationsConfigured, validated, and implemented the Quality Management System, Oracle AgileReviewed and approved manufacturing batch recordsDeveloped and managed a Quality Records group that reviews and approves deviation, laboratory investigation, CAPA, change control, and EV records

Education

• University of Maryland Baltimore County

  Bachelor of Arts, Biochemistry

• Notre Dame of Maryland University

  Master of Arts - MA, Management

Skills

• Pharmaceutical Industry
• Fda
• Life Sciences
• Quality Control
• Gmp
• Biotechnology
• Protein Chemistry
• Microbiology
• Analytical Chemistry
• Verification and Validation (V&V)
• Quality System
• Document Management
• Standard Operating Procedure (Sop)
• Chemistry
• 21 Cfr Part 11
• Glp
• Biopharmaceuticals
• Capa
• Chromatography
• Technology Transfer
• Lims
• Corrective and Preventive Action (Capa)
• U.s. Title 21 Cfr Part 11 Regulation
• Change Control
• Raw Materials
• Philosophy of Language
• Quality Assurance
• Pharmaceutics
• Laboratory Information Management System (Lims)
• Validation
• Biochemistry
• U.s. Food and Drug Administration (Fda)