Quality Assurance Coordinator

2 weeks ago


King of Prussia Pennsylvania, United States PSI CRO Full time
Job Description

As a Quality Assurance Assistant at PSI CRO, you will play a crucial role in ensuring the highest standards of quality in our operations. Your primary responsibilities will include:

Key Responsibilities
  • Quality Assurance Study Audits: Assist in scheduling and preparing quality assurance study audits, ensuring timely and efficient execution.
  • Internal Systems Audits: Collaborate with company divisions to schedule and prepare internal systems audits, maintaining the highest standards of quality.
  • Vendor Qualification Audits: Support the scheduling and preparation of vendor qualification audits, ensuring compliance with regulatory requirements.
  • Client/Third-Party Audits: Assist in scheduling, planning, and hosting client/third-party audits, ensuring seamless execution.
  • Audit Tracking and Reporting: Maintain accurate and up-to-date tracking logs for internal and external audits, vendor qualification audits, and CAPA investigations.
  • Quality File Management: Ensure the maintenance of the PSI Quality File, including documentation and records.
  • Organizational Chart Management: Update and maintain the PSI organizational charts, including group and country levels.
  • Documentation Assembly: Assemble internal systems/locations/study audits documentation, contracted audits documentation, and external audits of PSI documentation.
  • Quality Management Records: Develop and process Quality Management Records documenting QSD lifecycle, ensuring compliance with regulatory requirements.

Requirements

  • Strong understanding of quality assurance principles and regulatory requirements.
  • Excellent communication and interpersonal skills.
  • Ability to work in a fast-paced environment and prioritize tasks effectively.
  • Proficiency in Microsoft Office and ability to learn new software applications.


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