Bob

Quality Assurance Specialist

Summary

Bob is a seasoned Quality Assurance Consultant with over 20 years of experience in pharmaceutical and medical device manufacturing. He specializes in quality systems, validation, and regulatory compliance, bringing a proven track record of driving cost-effective solutions and achieving compliance with cGMP standards. Bob’s expertise spans diverse dosage forms, including sterile injectables, softgel capsules, and bulk powders, as well as medical devices like fixation implants and cutting instruments.

Core Expertise

  • Quality Management Systems (QMS) development 
  • Validation of processes, equipment, and utilities 
  • Regulatory compliance auditing for pharmaceutical and medical device manufacturing 
  • Risk-based validation planning and execution 
  • Technical writing for SOPs, CAPAs, and validation master plans 

Career Highlights

  • Medical Device Quality Assurance Engineer: Supported the manufacture of fixation implants, cutting instruments, and dental implants through quality assurance leadership. 
  • QA Consultant QMS Systems and Audit Specialist: Developed QMS and SOPs for virtual companies, audited Development and Commercial CDMOs, and conducted batch record reviews and product releases. 
  • Validation Specialist II: Led validation projects for sterile liquid drug products, including equipment, process, cleaning validations, and container closure integrity studies. 

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