4/15/14 – Quality Assurance Specialist

Accentuate Staffing is currently recruiting a Quality Assurance Specialist for a client of ours in RTP, NC.

Responsibilities

  • Maintain personnel training files
  • Generate and lead training programs for company SOPs and regulatory requirements
  • Generate and review SOPs, Quality Manuals, and Quality Action Plans
  • Test usability and quality impact of potential products
  • Provide ongoing QA support and work review as needed
  • Validate computer systems and carry out change control procedures
  • Create form and document templates
  • Conduct vendor audits for both current and potential vendors
  • Conduct periodic internal audits
  • Assist with new client support
  • Defend external audits of the organization
  • Assist in regulatory inspections

Requirements

  • Bachelor’s Degree in Scientific, Computer, or related discipline
  • Advanced Degree or Technical Certification(s) is preferred
  • 4+ years of experience in Quality Assurance, Quality Control, and/or Validation
  • Knowledge of ICH Guidelines for Good Clinical Practice, Title 21 of the Code of Federal Regulations, and Good Industry Practices involving Quality
  • Ability to read, write, speak, and understand English