Kimberly Kolosick

About Kimberly Kolosick

30+ Years Industry Experience ~ Technical Writing ~ Document Management and Change Control ~ Training (Technical, GxP, and Regulatory Compliance)~ Internal and External Supplier Auditing ~ Quality Management Systems (QMS)~ Risk Assessment and Management ~ Computer Systems Validation ~ Medical Device ~ Clinical Operations ~ Commercial Operations ~ Small and Large Molecule Product Manufacturing ~ Facilities Maintenance Operations ~ Electronic Document Management Systems (EDMS)~ Learning Management Systems (LMS)~ Computerized Maintenance Management Systems (CMMS)~ Six Sigma Green Belt Cert ~ FDA CFRs ~ Federal Department of Energy (DOE) Policies and Orders ~ ISO 9001 ~ European Medicines Agency (EMA)~ Health Canada ~OSHA10

Experience

1. Senior Manager Gts Quality Systems

   BeOne Medicines

   Jan 2024 — Present · US

Education

• California State University, Chico

  bachelor's, Journalism

  1986 — 1990

Skills

• Medical Devices
• Capa
• Regulatory Requirements
• Visio
• Internal Audit
• Quality Control
• Gmp
• Program Management
• Cross-Functional Team Leadership
• Technology Transfer
• Auditing
• Change Control
• Data Management
• Validation
• Iso
• Pharmaceutical Industry
• Sop
• Fda
• Continuous Improvement
• Training
• Biotechnology
• Lims
• U.s. Food and Drug Administration (Fda)
• Quality Assurance
• Management
• Computer System Validation
• Quality System
• Document Management
• Process Simulation
• Gxp
• Quality Auditing
• Iso 13485
• Quality Management
• Gcp
• Biopharmaceuticals
• 21 Cfr Part 11
• Change Management
• Process Improvement
• Software Documentation
• Regulatory Submissions