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Quality Assurance Systems Coordinator

2 months ago

Hercules, California, United States QuinTalent Inc Full time

Quality Assurance Systems Coordinator

This role is designed for individuals pursuing a degree in Molecular Biology, Chemistry, or Biotechnology. The position entails part-time work, focusing on supporting the implementation of Design History File management within a global electronic Quality Management System (eQMS).

The primary responsibilities of the Quality Assurance Systems Coordinator include:

  • Gathering legacy product documentation that needs to be integrated into the new eQMS, collaborating with subject matter experts (SMEs) to define metadata and ensure all necessary supporting documents are included.
  • Updating procedures, work instructions, and templates as they transition from the previous document control system to the new eQMS.
  • Collaborating with global teams to assess legacy Design History Files (DHF) affected by ongoing change control initiatives, determining the need for manual migration and facilitating document workflows as necessary.
  • Working with SMEs to revise other Quality Management System (QMS) and DHF documentation, coordinating the review and approval processes within the eQMS.

Impact on the Organization:

  • Fostering a culture of quality by collaborating with design and sustaining teams to ensure compliant and accurate product Design History Files (DHF), including the establishment of proper binder structures in the eQMS.
  • Ensuring that updates to procedures, work instructions, and templates are completed in accordance with project timelines.
  • Demonstrating adaptability in a dynamic environment while providing support to cross-functional teams as priorities shift.
  • Exhibiting self-motivation and accountability for assigned tasks.

Qualifications:

  • A Bachelor’s degree in Biology, Chemistry, or a related life science field is preferred; college students are encouraged to apply.
  • 0-1 years of experience in a regulated manufacturing environment or a relevant combination of education and experience.
  • Strong attention to detail and the ability to manage multiple tasks effectively.