Keri Mattson
24723 Para Siempre, San Antonio,TX
Summary
Extensive management experience in Donor Services, Eligibility, and Training for both cadaveric and living donors. Expert knowledge of FDA-CFR 21 Part 1271, AATB Standards for Tissue Banking, and EBAA Medical Standards. Comprehensive work experience in all aspects of human allograft transplantation, and extensive working knowledge in FDA-CFR 21 Part 820, quality event handling, compliance, new product design, and processing techniques.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Manager of Donor Services
Integra LifeSciences
07.2021 - Current
- Provide leadership and ensure the operational success of the Donor Services Department.
- Implement metrics and KPI’s that demonstrate the effectiveness, timeliness and accuracy of the Donor Services Department and ensure continuous audit readiness.
- Hire and train all new staff for all cadaveric and birth tissue donor eligibility reviews.
- Prepare the department’s metrics, strategic planning, trend and graph metrics for weekly management meetings and QMR.
- Writing and implementing Donor Eligibility Standard Operating Procedures and Work Instructions.
- Manage event-handling processes from initiation to completion along side QS team. Non-conformances, CAPAs, and determining if an event is reportable.
- Ensuring metrics are achieved and developing/implementing corrective action plans as needed to achieve goals.
- Conduct internal and desktop audits as well as conduct critical and non-critical supplier audits.
Manager of Donor Services
Stability Biologics
05.2019 - 07.2021
- Manage the Donor Services team’s daily workflow within the department.
- Train new staff for all cadaveric and birth tissue donor eligibility reviews.
- Acquiring and maintaining relationships with birth tissue and cadaveric tissue partner/suppliers.
- Prepare my department’s metrics, strategic planning, trends and graphs for weekly management meetings.
- CQI and SOP writing and revisions to streamline processes.
- Manage event-handling processes by completing complaint investigations, initiating and investigating non-conforming events, performing CAPAs, and determining if an event is reportable.
- Maintain event handling database and logs to ensure they are current.
- Obtain time sensitive records from partner agencies, medical examiners/coroners, medical directors, hospitals, and partner laboratories.
- Conduct internal and desktop audit reports as well as conduct critical and non-critical supplier audits.
- Employee training and training file compliance per standards.
Senior Medical Director Designee and Donor Services Coordinator
CorneaGen - San Antonio Eye Bank
03.2011 - 05.2019
- Oversee the daily workflow for all cadaveric donor records, complete eligibility for all cadaveric donors, serological and micro result interpretation and review, and medical records for same day release for transplant.
- Schedule and maintain administrator on-call operations.
- On Call Administrator (24 hours) every Sunday, Monday, Tuesday and Thursday.
- Request information from partner agencies, laboratories, hospitals, referral organizations and medical examiner’s office.
- Manage event-handling processes by completing complaint investigations, investigating non-conforming events, performing CAPAs, and determining if an event is reportable.
- Maintain event handling database and logs to ensure they are current.
- Ensure environmental and temperature monitoring is completed timely, correctly, and without lapse.
- Track and trend results.
Emergency Room - Paramedic
University Hospital - University Health System
03.2008 - 03.2011
- Providing emergency care to trauma and medical related emergencies in a level I Emergency Department.
Assistant Laboratory Manager
Cedra Clinical Research LLC
02.2007 - 11.2008
- Responsible for ensuring that day to day operations run smoothly by scheduling staff, reordering supplies, and maintaining security standards and safety of patients and staff
- Hiring and training of new staff
- Quality, safety, and auditing as directed by supervisor
Emergency Medical Technician Paramedic
American Medical Response
05.2003 - 01.2007
- Responded to all county 911 calls as Critical Care EMT-Paramedic with a solid ability to perform advanced technical, medical, and trauma related skills with a high degree of accuracy.
- Able to understand and effectively deal with emotional and medical needs of victims with injuries, acute illnesses, traumas, and psychological emergencies while maintaining a professional and objective approach
Education
Bachelor Emergency Health Sciences - Paramedicine - Paramedicine
University Texas Health Services Center At San Antonio
San Antonio, TX05.2006
Skills
- Cadaveric and Birth Tissue Eligibility Determination
- Complaint Investigations and Non-Conforming Events
- CAPA and Root Cause Analysis
- FDA/ISO/AATB/EBAA Compliance
- Implement Metrics and KPI's
- Supplier Qualification and Audits
- GAP Analysis
- CQI and SOP writing
- Aseptic Allograft Processing
- Cleanroom Environmental Monitoring
- Allograft Packaging and Distribution
- Project Planning
- Conducting Staff Performance Reviews
- Supplier Quality
Certification
- Certified Eye Banking Technician (CEBT), 2016
- Six Sigma – Certified Yellow Belt Professional, 2019
- Certified Tissue Bank Specialist (CTBS), 2022
- Six Sigma – Green Belt (in process)
References
References available upon request.
Timeline
Manager of Donor Services
Integra LifeSciences
07.2021 - Current
Manager of Donor Services
Stability Biologics
05.2019 - 07.2021
Senior Medical Director Designee and Donor Services Coordinator
CorneaGen - San Antonio Eye Bank
03.2011 - 05.2019
Emergency Room - Paramedic
University Hospital - University Health System
03.2008 - 03.2011
Assistant Laboratory Manager
Cedra Clinical Research LLC
02.2007 - 11.2008
Emergency Medical Technician Paramedic
American Medical Response
05.2003 - 01.2007
Bachelor Emergency Health Sciences - Paramedicine - Paramedicine
University Texas Health Services Center At San Antonio
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