Hybrid Quality Assurance Specialist

Posted 3 weeks ago

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About the role

  • Supports and assesses quality and compliance processes in healthcare at Grifols. Engaging in audit planning, regulatory inspections, and ensuring adherence to quality standards.

Responsibilities

  • Supports and assesses activities to ensure adherence to quality and compliance processes
  • Coordinates with donor centers for external inspections
  • Aids with audit planning and responses
  • Responsible for developing and reviewing audit responses / CAPA plans
  • Ensures compliance with Domestic / European regulations through routine review

Requirements

  • Bachelor’s Degree Required
  • 5 years of experience
  • Knowledge of the Code of Federal Regulations (CFR)
  • Understanding of the European Pharmacopoeia (EP) and other European Guidelines
  • Ability to write clear, concise, logical responses to regulatory authorities
  • Strong interpersonal skills

Benefits

  • Medical
  • Dental
  • Vision
  • PTO
  • up to 5% 401(K) match
  • tuition reimbursement

Job title

Quality Assurance Specialist

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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