Quality Systems Specialist - Cambridge, United States - Katalyst Healthcares & Life Sciences

Katalyst Healthcares & Life Sciences

Verified Company

Cambridge, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Responsibilities:

As a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Quality Management Systems (QMS) team by maintaining compliance with Client policies, QMS standards, and local regulations. You will report to the QMS Manager.
This position provides the opportunity to work directly with Manufacturing, Facilities, QA, and QC staff to manage QA Compliance activities for the Binney St. site in Cambridge, MA. The primary focus of this role will be to support management of Quality Systems (deviation, CAPA, and change control). Other activities may arise.
Manage overall health of Quality Systems by trending Key Performance Indicators (KPIs) to support continuous improvement and to identify, escalate, and resolve abnormalities or concerns.
Ensure quality operations and processes are in full compliance with Client standards and policies, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and local regulatory requirements.
Compile and analyze metrics for documentation, deviation, CAPA, and change control. Develop and maintain dashboards and presentation graphics on a regular basis.
Coordinate and facilitate recurring governance meetings with task owners across departments to manage timelines.
Lead improvement projects to streamline and simplify processes in alignment with company standards and regulations.
Perform Quality System process confirmations to ensure processes and systems are appropriately managed. Ensure audit readiness for Quality Systems at the site.
Support Quality Systems risk identification and timely mitigation activities.

Requirements:

High attention to detail.
Strong analytical and organizational skills.
Familiarity with Quality Systems (deviations, CAPAs, and change controls)
Proficiency in:
Excel and Smartsheet data analysis
Making clear, concise, and consistent PowerPoint presentations.
Confident facilitation skills to lead governance meetings and work with task owners to monitor timelines.
Professional demeanor when presenting to senior leadership.