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Regulatory Compliance Officer

2 months ago

New Haven, Connecticut, United States Katalyst HealthCares & Life Sciences Full time
Job Summary

Katalyst HealthCares & Life Sciences is seeking a highly skilled Quality Assurance Specialist to oversee the quality activities of our clinical research site in New Haven, CT. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and clinical research.

Key Responsibilities:
  • Quality Assurance and Compliance: Ensure that all quality activities are conducted in accordance with relevant regulations and standards, including Good Clinical Practice, FDA, and sponsor requirements.
  • Equipment Management: Oversee the handling, inventory, and storage of clinical equipment to meet regulatory requirements.
  • Documentation and Record-Keeping: Develop and maintain accurate documentation to record and support quality activities, including equipment calibration, IQ, OQ, and PQ.
  • Quality Oversight: Identify the level of quality activities needed for clinical trial site equipment and supplies, and support scheduling for installation, calibration, and qualification.
  • Policy and Procedure Development: Create policies, procedures, protocols, reports, and plans as necessary to meet regulatory needs, and work directly with client-qualified personnel for execution.
  • Training and Development: Develop SOPs, training materials, and other related quality system document requirements to ensure compliance and quality.
Requirements:
  • Strong background in quality assurance, regulatory compliance, and clinical research.
  • Excellent communication and project management skills.
  • Ability to work independently and as part of a team.
  • Strong attention to detail and organizational skills.