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Amy A. Email & Phone Number

Director of Quality Systems at Center for Organ Recovery & Education
Location: Virginia Beach, Virginia, United States 8 work roles 5 schools
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Role
Director of Quality Systems
Location
Virginia Beach, Virginia, United States
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Who is Amy A.? Overview

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Amy A. is listed as Director of Quality Systems at Center for Organ Recovery & Education, a with 841 employees, based in Virginia Beach, Virginia, United States. AeroLeads shows a matched LinkedIn profile for Amy A..

Amy A. previously worked as Senior Director, Quality Engineering and Risk Management at Lifenet Health and Senior Director Tissue Quality at Lifenet Health. Amy A. holds Doctor Of Science, Health Services/Allied Health/Health Sciences, General from Eastern Virginia Medical School.

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Email format at Center for Organ Recovery & Education

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Center for Organ Recovery & Education

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Profile bio

About Amy A.

Experienced Senior Director Of Quality Engineering and Risk Management with a demonstrated history of working in a highly regulated industry. Skilled in Good Laboratory/Manufacturing/Other Practices (GxP) as defined by the FDA, Operations Management, International and domestic regulations and accrediting bodies, and leadership principles. Strong quality assurance professional with extensive education in natural sciences, leadership, engineering, and organizational development. Many years of experience in leadership, quality, manufacturing, regulations, cellular therapy, and tissue banking. Medical device manufacturing experience.

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Center for Organ Recovery & Education
Center For Organ Recovery & Education
Director of Quality Systems
Chesapeake, VA, US
Employees
841
AeroLeads page
8 roles

Amy A. work experience

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Senior Director, Quality Engineering And Risk Management

Current
Oct 2021 - Present

Senior Director Tissue Quality

Virginia Beach, Virginia

Jan 2019 - Apr 2022

Director Tissue Quality

Virginia Beach, Va

Feb 2016 - Apr 2022

Manager Of Cellular Therapy Laboratory

Grand Rapids, Michigan

Oversees the Cellular Therapy Laboratory located at Michigan Blood including:• Operation and management of the public cord blood bank and stem cell processing laboratory• Quality control, maintenance, and validation of all storage, processing, facilities, and related equipment• Annual and as needed reporting to FDA, NMDP, accrediting bodies, and funding sources• Management and training of employees • Distribution of cord blood units and stem cell products to transplant centers• Directly responsible for biologics license application (BLA) for cord blood to the Food and Drug Administration and all data supplied for BLA • Maintaining AABB accreditation• Conduct CAPA reports, investigate reportable events, and conduct specialized investigations according to cGMP• Annual budgeting for cord blood bank and stem cell laboratory

Mar 2014 - Feb 2016

Cellular Therapy Manager

Lifesouth Community Blood Centers

Collects, processes, stores and distributes stem cells for transplantation. Recently received licensure from the FDA for cord blood products.

Sep 2010 - Mar 2014

Continuous Quality Improvement Coordinator

Duties included: • Conducting priority reviews on high profile child welfare cases • Oversight of peer record reviews • Supervisor system reviews • Participation and leading quality improvement teams • Ensure Council on Accreditation standards met and maintain accreditation

Jan 2009 - Aug 2009

Director Of Operations

Duties and responsibilities included:• Maintained budget of approximately $3.3 million • Professional development and safety of 50 employees and the safety of 450 children • Provided oversight to case management services in Hardee, Highlands, and Polk Counties • Provided direct supervision of unit supervisors and other staff as necessary• Adhered to contractual obligations with the funding sources • In conjunction with the Senior Vice President and Supervisors, handled client, staff or collateral complaints and grievances • Evaluated service delivery and implemented improvements• Worked with personnel and contract stakeholders to ensure quality of service and the achievement of program outcome goals• Ensured that services are provided in accordance with laws, regulations, contract requirements, quality standards and practices and the capacity of staff to improve the efficiency and quality of work performance and work products• Participated and represented the agency at various groups to promote agency programs and networking with the community • Maintained positive and open communication with the Lead Agency and partnered with the Lead Agency to maximize positive outcomes for children and families

Jul 2003 - Jan 2009
Team & coworkers

Colleagues at Center for Organ Recovery & Education

Other employees you can reach at lifenethealth.org. View company contacts for 841 employees →

5 education records

Amy A. education

Bachelor Of Chemical Engineering, Chemical Engineering

Activities and Societies: Member of Omega Chi Epsilon Honor Society for Chemical Engineers Member of Tau Beta Pi Honor Society.

FAQ

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What company does Amy A. work for?

Amy A. works for Center for Organ Recovery & Education.

What is Amy A.'s role at Center for Organ Recovery & Education?

Amy A. is listed as Director of Quality Systems at Center for Organ Recovery & Education.

Where is Amy A. based?

Amy A. is based in Virginia Beach, Virginia, United States while working with Center for Organ Recovery & Education.

What companies has Amy A. worked for?

Amy A. has worked for Center For Organ Recovery & Education, Lifenet Health, Michigan Blood, Lifesouth Community Blood Centers, and One Hope United.

Who are Amy A.'s colleagues at Center for Organ Recovery & Education?

Amy A.'s colleagues at Center for Organ Recovery & Education include John Halstead, Calleigh Scott, Lorrie Webb, Tiffany Cynar, and Christian Stiller.

How can I contact Amy A.?

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What schools did Amy A. attend?

Amy A. holds Doctor Of Science, Health Services/Allied Health/Health Sciences, General from Eastern Virginia Medical School.

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