Amanda Ulrey

President at Institute for In Vitro Sciences, Inc.
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Contact Information
us****@****om
(386) 825-5501
Location
US

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John Harbell

Outstanding leader in Quality Assurance. Successful audits from client companies and regulatory agencies over the past decade attest to her skills and leadership.

Alexander Samodurov

It's clear why Mandy is Head of QA at IIVS. She has a frighting capacity for detail and a drive for thoroughness that can be quite breathtaking to behold. Working with her as primary contact over the duration of a complete content management system implementation and website redesign was a pleasure and one of the smoothest client engagements I've ever enjoyed.

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Credentials

  • Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP)
    Society of Quality Assurance
    Jan, 2005
    - Nov, 2024

Experience

    • United States
    • Research Services
    • 1 - 100 Employee
    • President
      • Jan 2023 - Present

    • Vice President, Business Operations
      • Jul 2020 - Present

    • Director, Quality and Compliance
      • Aug 2015 - Present

      The Director of Quality and Compliance is primarily responsible for instituting and fostering a culture of quality management and compliance throughout the organization. The Director of Quality and Compliance provides leadership, training and oversight of the Quality Assurance Unit, Information Technology, and Archivist functions; institutes and maintains policies and procedures for regulatory compliance and organizational quality programs; maintains currency in quality management principles; and advises IIVS' Officers of best industry practices for organizational quality management programs.

    • Head of Quality Assurance/ Manager, Marketing and Client Services
      • Jun 2002 - Present

      • Responsible for maintenance of the on-site quality assurance program and management of quality assurance/client services personnel.• Perform audits of workbooks, and draft and final reports of GLP studies.• Conduct vendor and subcontractor audits and host sponsor and government audits of the IIVS facility.• Perform consulting work as requested by sponsors, including development of a QA/QC program for a novel three dimensional tissue construct manufacturing facility and development of an audit program for background review documents.• Serve as the primary liaison between the Institute and its clients by performing such functions as: interacting with customers as they place studies, responding to inquiries for information and pricing, generating quotations and coordinating client visits.• Create marketing literature and build a sales program that accurately reflects the current testing program.• Maintain appropriate pricing of all assays.• Serve as lead in validation of IIVS’s computer systems.• Organize and coordinate workshops and trade shows.• Assist in web site design and maintenance.• Interact with industry, animal welfare groups and government as necessary to discuss use of in vitro methods.

    • Dance Instructor
      • Aug 2008 - Present

      Dance Instructor for all age groups in jazz, tap, lyrical, modern/contemporary, hip hop, and beginner level ballet. Dance Instructor for all age groups in jazz, tap, lyrical, modern/contemporary, hip hop, and beginner level ballet.

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Associate Production Supervisor, Veterinary Services and In Vivo Testing
      • May 2001 - Apr 2002

      • Performed first line supervisory duties for seven PACE Union Testing Technicians within a cGMP laboratory. Included scheduling daily as well as overtime duties, handling complaints, training new employees and answering questions pertaining to the assays performed. • Authored, evaluated and revised Standard Operating Procedures, Control Procedures and Process Specific Training Modules. • Scheduled samples for testing in line to meet established Operational Excellence goals and operation due dates. • Served as a liaison between the testing lab and manufacturing and research areas by answering assay specific questions and providing technical support as needed.

Education

  • The Johns Hopkins University
    MS, Bioscience, Regualtory Affairs
    2008 - 2013
  • Cedar Crest College
    B.S., Biology
    1997 - 2001

Community

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