Jennifer Carthy

Background

About Jennifer Carthy

As a Quality Systems Specialist, I support the global Quality Systems and provide day to day support for key processes within the company-wide Quality Management System (QMS). I adhere to company policies and procedures and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements. Accountabilities & Responsibilities: Manages, publishes, and controls updates to company-wide Quality Management System documents while ensuring their accuracy, quality, and integrity. Collaborates with cross-functional teams to support the development and approval of changes to the QMS. Ensures company-wide document changes meet procedural requirements and submits feedback to owners, as needed. Processes changes to company-wide QMS documents, including initiating redlines, assigning document numbers, submitting changes, for approval and gaining approval. Ensures that documents are approved in a timely manner and follows up with process owners, as needed. Releases approved controlled documents, ensures documents are posted at points of use, and notifies key stakeholders. Manages the document translation process with internal and external stakeholders, including requesting translations, coordinating review with internal stakeholders, and communicating feedback to external stakeholders. Controls external documents, including tracking such changes and coordinating change impact assessments with internal subject matter experts. Prepares reports and/or necessary documentation and provides to applicable stakeholders, both internal and external. Analyzes processes, procedures, data, risks, and work structure to create solutions for overall efficiency improvements. I love being a part of an organization that helps people succeed. I'm a hard worker, determined and I strive for the best. My favorite part about my job is knowing that I can help others with their career goals, while continuing to learn something new everyday at work as well. It's exciting and amazing to watch the growth of those you serve grow and succeed along the way. I have a passion for interpreting and analyzing data to help the company to achieve its goals and keep up with the market standard and its competitors.