Patient Safety Operations Specialist, Onsite

Job Description
We're seeking a skilled Patient Safety Operations Specialist (RN) to help maintain our commitment to excellence. As a Patient Safety Operations Specialist, you will ensure that all goals are met and that our practices and procedures comply with company policies. Responsible for maintaining compliance with FDA, AATB, and international and state regulations during the second-level quality review of all tissue donor files for tissue submitted to AbbVie to ensure the safety of donated human tissue. It will also support the triage and review of information received after the initial donor release to assess the potential impact on donor suitability and distributed products, triggering escalation procedures and evaluation for regulatory action.
Join our team of dedicated professionals and take your career to the next level. Apply now to become a part of our organization and help us maintain our commitment to excellence.
Responsibilities:
Quality Operations - Responsible for the processing and maintenance of SOPs for the business segment. Compiles quality data and trends for Quality Management and Product Reviews.
Quality and Regulatory Compliance - Provides support and management of regulatory inspections and tracking inspectional responses. Training coordinator function responsibilities.
Quality Systems - Maintains knowledge in both current and emerging GxP requirements and quality trends as they relate to Medical Device and Combination Products worldwide and supports and executes changes to quality standards/policies to ensure conformance.
Organization Effectiveness and Strategic Direction - Types routine memos and letters, composes correspondence, schedules meetings, sets up filing systems, gathers information, answers questions on department and company policies and procedures, prepares basic reports, compiles statistics, and sets up databases.
Assists with special projects, collecting and collating documents and materials as requested.
Assists functional area, to compile and generate reports, timelines, correspondence and presentations.