Quality Systems SpecialistKatalyst HealthCares & Life Sciences • San Mateo, CA
Quality Systems Specialist
Katalyst HealthCares & Life Sciences • San Mateo, CA
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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.
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 :
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Quality Specialist • San Mateo, CA
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