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Quality Systems Specialist
Quality Systems SpecialistKatalyst HealthCares & Life Sciences • San Mateo, CA
Quality Systems Specialist

Quality Systems Specialist

Katalyst HealthCares & Life Sciences • San Mateo, CA
30+ days ago
Job type
  • Full-time
Job description

Responsibilities:

  • Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance with Quality Management System (QMS) expectations.
  • Navigate complex change review discussions, facilitating decisions regarding approach and follow-up actions, and document these evaluations.
  • Support management and monitoring of change records for adherence to organizational or departmental metric targets and maintain associated tracking tools and databases.
  • Assist in the management review process by developing and generating quality system metrics and trends, escalating issues as necessary.
  • Contribute to the maintenance and improvement of quality systems processes as needed.
  • Collaborate directly with operating entities and internal clients to ensure follow-up on change tasks.
Requirements:
  • + years of relevant experience in a GMP environment for biologics manufacturing with a BS or BA, including mandatory change control experience.
  • + years of relevant experience with a MS degree.
  • Change control experience from a regulated industry such as medical device, pharma, nutraceuticals, or vitamins, with FDA-related knowledge.
  • Strong communication skills, good time management skills, and attention to detail.
  • Knowledge of good technical writing.

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Quality Systems Specialist • San Mateo, CA

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