Quality Systems Specialist
Employment Type: Full-Time
The Role Supports administration for CAPA, Investigation, and Deviation systems. Includes, facilitating the closure of items with the applicable departments to ensure completion and timely resolution. Responsible for tracking and trending aspects of the Quality System and provide reports to management identifying risks and trends on a
routine basis. Performs CAPA effectiveness evaluation based on quantitative and qualitative measurements. Administer the Change Control process for the site and conduct effectiveness verification for changes implemented. Maintains tracking mechanisms to support various Quality Systems elements and ensures visibility throughout the organization Continuously monitor and review systems and procedures for adherence to regulatory compliance, quality improvements, efficiency and industry best practices. Coordinates on-site client audits, preparation of audit materials, and ensure timely response and resolution to client observations.
The Candidate Minimum of a B.S. in a Life Sciences discipline 6 years’ experience in a GMP environment with at least 4 of those years in a Quality/Compliance function Have the knowledge, and ability to apply basic scientific and regulatory principles to improve quality systems ASQ (American Society of Quality) or RAPS (Regulatory Affairs Professionals Society) highly desirable
Catalent’s standard leadership competencies that are used to interview and for Performance & Development Leads with Integrity and Respect Delivers Results Demonstrates Business Acumen Fosters Collaboration and Teamwork Champions Change Engages and Inspires Coaches and Develops
Potential for career growth within an expanding team Defined career path and annual performance review & feedback process Cross functional exposure to other areas of within the organization Medical, Dental, Vision, and 401K are all offered from day one of employment 19 days of paid time off annually + 7 paid holidays
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