Quality Assurance Specialist

hace 3 semanas


Sabana Llana Sur Barrio, Puerto Rico Katalyst Healthcares And Life Sciences A tiempo completo

Job Summary

Katalyst Healthcares And Life Sciences is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes, and for maintaining compliance with regulatory requirements.

Key Responsibilities

  • Assist with the integration and support of quality regulations for drug, biologics, device, and combination products.
  • Support project teams in planning, preparation, review, and approval of quality documentation.
  • Complete and route change requests for process document creation, maintenance, and implementation.
  • Create quality system documentation and specifications with guidance from technical teams.
  • Assist with or co-lead audits of documentation, facilities, and equipment.
  • Assist in the design of effective quality systems, procedures, and processes within cross-functional teams.
  • Perform assessments to determine compliance with processes and regulations.
  • Participate in training and education programs for various aspects of quality assurance.

Requirements

  • Bachelor's degree in chemistry, pharmacy, biology, microbiology, engineering, or other technical/scientific area.
  • 3+ years' experience in quality assurance, quality oversight, or relevant experience.
  • Technical knowledge in quality, regulatory, process sciences, manufacturing operations, and GMP compliance requirements.
  • Excellent communication and interpersonal skills.


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