Quality Assurance Specialist

4 days ago


New Haven, Connecticut, United States Katalyst HealthCares & Life Sciences Full time
Job Title: Quality Assurance/Activities

Katalyst HealthCares & Life Sciences is seeking a highly skilled Quality Assurance/Activities professional to join our team.

Responsibilities:
  • Ensure compliance with relevant regulations and standards, including Good Clinical Practice, FDA, and sponsor requirements.
  • Oversee the handling, inventory, and storage of clinical equipment and supplies to meet regulatory needs.
  • Develop and implement quality policies, procedures, and protocols to support clinical trial site operations.
  • Identify and implement quality activities needed for clinical trial site equipment and supplies.
  • Support scheduling for installation, calibration, and qualification of clinical equipment.
  • Author and create quality-related documents, including policies, procedures, protocols, reports, and plans.
  • Develop and maintain SOPs, training materials, and other quality system documents.
Requirements:
  • Strong knowledge of regulatory requirements and industry standards.
  • Excellent communication and project management skills.
  • Ability to work independently and as part of a team.
  • Strong analytical and problem-solving skills.


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