Quality Assurance Specialist

4 weeks ago

Skaneateles, New York, United States Katalyst Healthcares & Life Sciences Full time
{"title": "Quality Associate II", "description": "Job Summary

We are seeking a highly skilled Quality Associate II to join our team at Katalyst Healthcares & Life Sciences. This role will be responsible for managing and continuously improving the CAPA program, as well as providing quality support and oversight to ensure compliance with regulatory agency rules and guidelines.

Key Responsibilities
  • Manage and continuously improve the CAPA program to ensure effective risk management and compliance.
  • Provide quality support and oversight to ensure compliance with regulatory agency rules and guidelines.
  • Identify and assess regulatory and quality risks in activities and processes.
  • Develop and implement corrective action plans to address identified risks.
  • Collaborate with production supervisors, quality, engineering, and other internal groups to ensure effective risk management and compliance.
  • Develop and maintain Standard Operating Procedures (SOPs) to ensure compliance with regulatory requirements.
  • Participate in external assessments and audits to ensure compliance with regulatory requirements.
Requirements
  • Bachelor's degree in business or science.
  • 3-5 years of experience in quality with a medical background.
  • Strong interpersonal skills and attention to detail.
  • Ability to manage people, encourage teamwork, and drive decisions.
  • Knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
", "lang_code": "en"}

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