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Ensure CAPA processes and procedures are followed, to ensure alignment with Fortune Brands global Quality processes. Achieve defined metrics for CAPA timeliness and efficacy, in support of FBIN objectives around safety, quality, service and cost.
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The successful candidate will have a minimum of 5 years of hands-on experience supporting, developing, and administering Trackwise EQMS and other similar Quality Management Systems, with a specific focus on Java based application development in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
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Ability to monitor the QMS such as: Change Control, CAPA, Complaints, Nonconforming Materials and Products. Tracking/trending aspects of the QMS.Other job duties as requiredExperience:Minimum 3 years' experience in Quality or Regulatory, preferably in a medical device, pharmaceutical or biotechnology environment/industry.
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I.e. LEAN, Six Sigma, Kaizen, CAPA, etc.) Demonstrated experience in Food Safety, Regulatory, and Quality Systems and their application within food processing preferred. Expert abilities and decision quality in Food Safety, Regulatory, and Quality Systems and their application within food processing.
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Ability to monitor the QMS such as: Change Control, CAPA, Complaints, Implement and handle CAPA (Corrective and Preventive Actions) and problem resolution. Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for site.
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Lead initiatives to enhance the effectiveness of the QMS, including change control, deviation management, and CAPA systems. Provides GMP Quality Assurance oversight of AVEO products manufactured at Contract Development Manufacturing Organizations (CDMOs.
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Ensure Corrective and Preventive Action (CAPA) process for sanitation, pest management, and hygienic design improvement plans are followed. Working knowledge of regulatory and quality system and sanitation requirements: Global Food Safety Initiative (GFSI), Safety Quality Food (SQF), Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), Environmental Microbiological Monitoring Program (EMMP), Master Sanitation Schedule (MSS), Integrated Pest Management (IPM), CIP/COP, etc.
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Raising an IT CAPA, initiation, action processing, root cause analysis. Computer System Validation (CSV) Lead with experience in Veeva Vault Platform, Clinical applications, Quality Management Systems and Document Management Systems.
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Certified Ambulatory Peri-anesthesia Nurse (CAPA) This role supports strategic planning, access strategy, operations, financial management, quality initiatives, regulatory compliance, and system integration while fostering an inclusive and collaborative culture.
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Reporting to the Chief Nursing Officer (CNO), the Associate Vice President (AVP), Perioperative and Procedural Areas is responsible for the centralized leadership and operations of all perioperative and procedural areas at UF Health Jacksonville, including operating rooms, post-anesthesia care units, pre-operative areas, endoscopy suites, sterile processing, interventional radiology, and ambulatory surgery center.
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The AVP, Perioperative and Procedural Areas, collaborates closely with senior leadership to develop and execute strategic plans that align with the mission, vision, and values of UF Health Jacksonville across perioperative and procedural areas, utilizing data, best practices, and national benchmarks to continuously improve processes and achieve excellence in perioperative nursing and surgical services across the continuum of care.
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CAPA: Must be cleared by the NYS Central Register for Child Abuse and Maltreatment, if position requires working with minors and not previously cleared. Duties Description POSITION DESCRIPTION:Under the supervision of the Day Program Director, the Day Service Coordinator is responsible for the development, documentation, and implementation of Day Habilitation services for individuals who live in both state and voluntary operated residential programs.
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Strong working knowledge of complex blueprint reading, statistical methods, problem solving, 5S/LPA, CAPA, SPC, APQP, MSA, GD&T, Customer QBRs, quality standards, quality audits and continuous improvement tools.
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Associate's degree in nursing is considered only with relevant experience and/or active matriculation in a BSN Program if approved by Chief Nursing Officer or designee + 2 Years ASU experience + Licensed as a registered nurse with current registration in New York State + BCLS, ACLS and PALS from AHA required + CAPA.
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Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for the site. Working knowledge of ISO standards and Quality Management Systems (QMS.
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capa job Title: quality coordinator Company: Intertek Us
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