Quality Assurance Specialist

5 days ago

California, United States TotalMed, Inc. Full time
Job Title: Quality System Specialist

At TotalMed, Inc., we are seeking a highly skilled Quality System Specialist to join our team.

Job Summary:

The Quality System Specialist will be responsible for assisting in the development, implementation, and maintenance of our quality management systems (QMS) program. This includes overseeing eQMS records, such as Change Management, Deviations, and CAPAs, to ensure timely completion and compliance.

Key Responsibilities:

  • Support the implementation and maintenance of the quality systems program
  • Assist with the oversight of the Corrective and Preventive Action (CAPA) process to ensure timely completion and compliance
  • Assist with the oversight of the Change Management program to ensure continuous compliance of the Quality System
  • Assist with the oversight of the Deviation process to ensure timely completion and compliance
  • Manage electronic Quality Management System (QMS) (e.g., Veeva Vault QMS), including troubleshooting issues and testing in the Veeva Sandbox environment
  • Review and execute PQ scripts within the Veeva Test environment
  • Ensure quality systems procedures, systems, and processes are effective and meet regulatory requirements and business needs
  • Provide support for internal audit and regulatory inspections of quality management systems

Requirements:

  • Bachelor's degree in Life Sciences or an equivalent combination of relevant education and applicable job experience
  • Minimum of 3 years Quality Systems experience
  • Proficiency in Microsoft Excel, Word, and Outlook
  • Critical thinking skills in analyzing and exercising judgment on complex issues
  • Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up, and judgment
  • Skilled at effectively communicating department or area issues and results within and across functional areas

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