Emily Holloway
Quality System Specialist at Lifelink Tissue Bank- Claim this Profile
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Bio
Credentials
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Quality Auditor
American society of qualityApr, 2019- Sep, 2024
Experience
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Lifelink Tissue Bank
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Quality System Specialist
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Jul 2023 - Present
Responsible for supporting all change management activities at LifeLink Tissue Bank to include Change Events, Planned Deviations, and Document Management functions. Responsible for supporting the initial evaluation and triage of Change Event Requests and Planned Deviation Requests as well as participating in the maintenance of the digital document management system. Responsible for filling Partner Surveys and Questionnaires. Responsible for supporting all change management activities at LifeLink Tissue Bank to include Change Events, Planned Deviations, and Document Management functions. Responsible for supporting the initial evaluation and triage of Change Event Requests and Planned Deviation Requests as well as participating in the maintenance of the digital document management system. Responsible for filling Partner Surveys and Questionnaires.
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LifeLink Foundation
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United States
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Hospitals and Health Care
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100 - 200 Employee
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Quality Assurance Specialist
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Sep 2022 - Present
Works as an individual contributor responsible for supporting the Audit system; this includes performing, hosting, reporting, tracking, and facilitating the resolution of audits, both internal and external. Active in the support of the Quality incident system; this includes identification, tracking, facilitation, investigation, reporting and completion of Quality Incident Reports. Quality Incident reports include deviations, non-conformances, complaints, & adverse events. Collaborates with other departments to support continuous improvement projects within the scope of Quality Assurance. Also collaborates with multiple departments to lead root cause investigations, facilitate problem-solving projects, and projects across the facility. Show less
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Boston Whaler
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United States
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Consumer Goods
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200 - 300 Employee
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Quality Assurance Specialist
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Oct 2021 - Sep 2022
Supervise and Manage the Quality Temp program. Created Training Manuals, including but not limited to Work Instructions and Process Instructions, for the Documentation Specialist Role and the Quality Temp Program. Lead Auditor of Construction Record Audits in the Electronic Quality Management System. Produce, manage and file all Boston Whaler Construction Records. Management of the Record Retention Storage Room. Implemented Inventory management and document retention standards for the Record Storage Room based on guidelines from Corporate. Project Lead and Mentor for various Continuous Improvement projects throughout both plants. Implementation of Good Documentation in Manufacturing Practices and standards for recording data in records. Quality Management System administration for internal production data collection and document control. Show less
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AlloSource®
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United States
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Medical Equipment Manufacturing
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200 - 300 Employee
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Quality System Specialist
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Jun 2019 - Jul 2021
Review submissions to Quality Management System (QMS) for spelling, punctuation, formatting, and assure appropriate review and approval. Ensure data integrity, company policy and regulatory requirements are being met. Initial point of contact for end users in terms of document control, training, system functionality, process set uprequirements, and resolution of discrepancies. Perform regular audits of the QMS to ensure compliance with controlled procedures and regulations. Manage and maintain specified QMS related policies and procedures, with oversight from the Quality Systems Manager. Oversight of the quarantine and non-conformance QMS. Assistance with CAPA program. QMS Training Administrator. Show less
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Acceptability Technician
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Mar 2017 - Jun 2019
Comply and adhere to FDA, CGTP. OSHA and SOP’s. Responsibility and authority to reject or approve tissue. Handles technical aspects of the quality control program within the controlled work area, donor receiving, and final labeling. Review of processing records, completion of quality documents, and visual inspection of in process and final tissue in accordance with applicable regulatory standards.
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Operations Technician
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Mar 2015 - Mar 2017
Working within a clean/aseptic environment. Manufacturing of various grafts from donated human tissue. Knowledge of the products and their applications. Adherence to SOP/GMP.
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Education
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2009 - 2014
Metropolitan State University of Denver
Psychology
Community
