Amanda White, MSci HRD, BS, LSSBB
Project Manager at FDAQRC- Claim this Profile
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Bio
Amy Wotawa
If I had to describe Amanda in only 3 words, I would use Driven, Proactive, and Collaborative. I had the pleasure to work with Amanda in maintaining and improving quality practices for the laboratory site she supervised. Amanda was one of my best allies in operations and showed great interest and acuity for quality management as I served as Regional Quality Assurance Manager for her laboratory. She is a lifelong learner with a high emotional IQ who builds and maintains trusted professional partnerships.
Dr. Lee Barbara Connally
I HIGHLY RECOMMEND THIS VERY TALENTED, EARNEST, DEPENDABLE, HIGHLY KNOWLEDGIBLE IN HER OCCUPATIONAL FIELD, & CONCIENTIOUS PROFESSIONAL!
Amy Wotawa
If I had to describe Amanda in only 3 words, I would use Driven, Proactive, and Collaborative. I had the pleasure to work with Amanda in maintaining and improving quality practices for the laboratory site she supervised. Amanda was one of my best allies in operations and showed great interest and acuity for quality management as I served as Regional Quality Assurance Manager for her laboratory. She is a lifelong learner with a high emotional IQ who builds and maintains trusted professional partnerships.
Dr. Lee Barbara Connally
I HIGHLY RECOMMEND THIS VERY TALENTED, EARNEST, DEPENDABLE, HIGHLY KNOWLEDGIBLE IN HER OCCUPATIONAL FIELD, & CONCIENTIOUS PROFESSIONAL!
Amy Wotawa
If I had to describe Amanda in only 3 words, I would use Driven, Proactive, and Collaborative. I had the pleasure to work with Amanda in maintaining and improving quality practices for the laboratory site she supervised. Amanda was one of my best allies in operations and showed great interest and acuity for quality management as I served as Regional Quality Assurance Manager for her laboratory. She is a lifelong learner with a high emotional IQ who builds and maintains trusted professional partnerships.
Dr. Lee Barbara Connally
I HIGHLY RECOMMEND THIS VERY TALENTED, EARNEST, DEPENDABLE, HIGHLY KNOWLEDGIBLE IN HER OCCUPATIONAL FIELD, & CONCIENTIOUS PROFESSIONAL!
Amy Wotawa
If I had to describe Amanda in only 3 words, I would use Driven, Proactive, and Collaborative. I had the pleasure to work with Amanda in maintaining and improving quality practices for the laboratory site she supervised. Amanda was one of my best allies in operations and showed great interest and acuity for quality management as I served as Regional Quality Assurance Manager for her laboratory. She is a lifelong learner with a high emotional IQ who builds and maintains trusted professional partnerships.
Dr. Lee Barbara Connally
I HIGHLY RECOMMEND THIS VERY TALENTED, EARNEST, DEPENDABLE, HIGHLY KNOWLEDGIBLE IN HER OCCUPATIONAL FIELD, & CONCIENTIOUS PROFESSIONAL!
Credentials
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Lean Six Sigma Green Belt (ICGB)
Six Sigma Academy AmsterdamSep, 2021- Nov, 2024 -
Society for Human Resource Management-Member
SHRMJun, 2020- Nov, 2024 -
Clinical Lab Specialist in Cytogenetics
American Society for Clinical PathologyOct, 2006- Nov, 2024
Experience
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FDAQRC
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Project Manager
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Apr 2021 - Present
As a project manager, I work to provide innovative solutions for your quality, training and compliance challenges. We analyze your needs and match the right expert to you situation. Our team includes former FDA and Health Authority experts, compliance officers and global industry professionals in quality assurance & regulatory affairs. As a project manager, I work to provide innovative solutions for your quality, training and compliance challenges. We analyze your needs and match the right expert to you situation. Our team includes former FDA and Health Authority experts, compliance officers and global industry professionals in quality assurance & regulatory affairs.
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UC Health
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United States
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Hospitals and Health Care
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700 & Above Employee
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Quality/Compliance Manager, Accreditation & Regulatory Affairs (Heme/Onc, Bone Marrow Transplants)
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Oct 2018 - Apr 2021
-Facilitated implementation of Quality Management principles and tools to that optimal quality of care, research and the highest level of patient safety and outcomes can be achieved. -Served as Authorized Representative for IEC/CAR T-cell products -Acted as Interim Breast Accreditation Manager for the Comprehensive Breast Cancer Center -Quality assurance, quality improvement and regulatory compliance activities oversight of the Bone Marrow Transplant (BMT) Program, including Perioperative Services, bone marrow collection, BMT and Hematology inpatient and ambulatory clinic areas and Cellular therapy. -Additionally, I assisted with quality and process improvement activities for other areas including inpatient units. -I frequently collaborated with hospital leadership, clinical customers, and unit staff on quality projects Show less
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Accupath Diagnostics Laboratories, Inc DBA Integrated Oncology
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Cincinnati Area
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Laboratory Supervisor
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Apr 2010 - Oct 2018
-Responsible for reference lab handling as well as troubleshooting review, evaluation, and case management to ensure optimal service level achievement -Draft SOPs, analytical protocols as well as new platform and on-going training in areas of flow cytometry, cell-mediated immunity and hematology -Facilitate work flow communication and overdue reports with virtual team members -Organize and maintain CLIA/CAP evidence of compliance -Meets Organization TAT/resulting goal of 90% for total volume. -Supported sister site Quality project work including KPI key performance indicator data compilation, input and analysis for internal departments -Developed novel solutions for service delivery -Verified compliance documentation satellite laboratories in network -Co-Authored 4 Academic journal articles while performing developmental delay testing for congenital disorders Show less
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Cincinnati Children's Hospital Medical Center
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United States
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Hospitals and Health Care
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700 & Above Employee
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Cytogenetic Technologist, Division of Human Genetics
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Jun 2005 - Apr 2010
-Performed various genetic testing, including: array hybridization, FISH hybridization and cytogenetic analysis (karyotype)-Participated in Continuing Education maintenance program-Presented case reviews in lab meetings, also provided education to newer employees-Assisted in department rotation of cell culture maintenance and harvesting
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Research Assistant, Division of Pulmonary Biology
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Jun 2003 - Jun 2005
-Conducted gene regulation and expression studies using animal models-Executed Molecular Biology techniques such as PCR and rtPCR, DNA sequencing to further elucidate disease-causing mechanisms-Assisted in ImmunoHistochemistry staining practices
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Education
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2017 - 2019
Xavier University
Master's degree, Human Resources Development -
2000 - 2003
University of Cincinnati
Bachelor of Science (BS), Biology/Biological Sciences, General -
1999 - 2000
Ohio University
Biology/Biological Sciences, General -
2006 -
ASCP
CLSp (CG) Cytogenetics
Community
