JANET HARRIS
Administrative Laboratory Director
Austin,TX
Summary
Focused Clinical Laboratory Director with a background spent in Quality and Operations overseeing budget, personnel and regulatory concerns. A highly collaborative leader committed to building strong integrated teams. Proven problem solver and excellent communicator. Strong organizational skills, adept at maintaining regulatory standards.
Overview
16
16
years of professional experience
2
2
Certifications
Work History
Director, Regional Clinic Laboratories
Baylor Scott & White
Austin, TX
08.2021 - Current
- Worked closely with organizational leadership and board of directors to guide operational strategy.
- Set strategic plans and goals to strengthen operations and drive growth.
- Evaluated company documentation to verify alignment with regulatory requirements.
- Established departmental performance goals and provided feedback for underperforming areas.
- Monitored and coordinated workflows to optimize resources.
- Monitored workflow and administrative processes to keep operations running smoothly.
- Oversaw operations and provided corrective feedback to achieve daily and long-term goals.
Senior Director of Quality
SIWA BIOTECH
Oklahoma City, Oklahoma
01.2019 - 08.2021
- Worked closely with organizational leadership and board of directors to guide operational strategy
- Directed overall activities required for development, execution, management, and sustainment of Quality Management Systems
- Lead Quality Unit in providing development, implementation, and management of GMP quality and compliance systems and policies, including development of QA and QC processes and procedures
- Advise senior management regarding quality and regulatory findings and recommendations
- Provide technical and quality oversight to operations to ensure GMP, Quality Management System and Regulatory compliance
- Oversee FDA lot release process including submissions and release of approved products to inventory
- Oversee product quality investigations and implementation/effectiveness of corrective and preventive actions (CAPA)
- Monitor quality of products / processes and implemented systems and strategies to ensure compliance with established regulatory guidelines
- Participate in FDA annual report development and submission
- Oversee in-sourcing of Environmental Monitoring (EM) and resultant ongoing performance.
- Set strategic plans and quality goals to strengthen operations and drive growth.
Manager
THE UNIVERSITY OF TEXAS, MD ANDERSON CANCER CENTER
Houston, TX
01.2016 - 01.2018
- Transfusion Service
- Led team of 45 medical technologists and technicians in testing 126,000 patient samples and dispensing 185,000 blood products per year
- Collaborated with finance department to develop, manage, and reconcile $4M budget within 3%
- Championed temperature monitoring for red blood cells that reduced wastage by 21% and saved $103,500
- Implemented massive transfusion protocol with transfusion service and anesthesiology medical directors
- Developed quality indicators and reported results to medical staff committee
- Established performance goals for employees and provided feedback on methods for reaching those milestones.
Director
BIOBRIDGE GLOBAL
San Antonio, TX
01.2010 - 01.2016
- GenCure Subsidiary
- Established quality assurance department with 6 specialists resulting in standardized monitoring of regulatory compliance
- Developed and implemented new processes and procedures resulting in consistent practices, reduced turnaround time, and streamlined efficiencies in lot release processes
- Oversaw corrective and preventive action (CAPA) system; performed appropriate root cause analyses; resulting in improved deviation turnaround and closure time
- Worked closely with organizational leadership and board of directors to guide operational strategy
- Evaluated company documentation to verify alignment with regulatory requirements
- Established departmental performance goals and provided feedback for underperforming areas
- Remained composed and highly professional in fast-paced and constantly changing environment, effectively handling challenging situations and difficult individuals to achieve objectives
Quality Assurance Coordinator
BAPTIST HEALTH SYSTEM
San Antonio, TX
01.2006 - 01.2010
- Coordinated performance and process improvement for five clinical laboratory satellites
- Tracked, analyzed, and reported clinical laboratory performance data to medical and administrative staff
- Managed external laboratory accreditation audits / inspections and response process
- Coordinated proficiency testing result review and evaluation across medical directors and satellites
Education
Master of Business Administration -
Abilene Christian University
Bachelor of Science - undefined
Texas A&M University
Skills
Operations management
Certification
Medical Laboratory Scientist (ASCP #149399)
Timeline
Director, Regional Clinic Laboratories
Baylor Scott & White
08.2021 - Current
Senior Director of Quality
SIWA BIOTECH
01.2019 - 08.2021
Manager
THE UNIVERSITY OF TEXAS, MD ANDERSON CANCER CENTER
01.2016 - 01.2018
Director
BIOBRIDGE GLOBAL
01.2010 - 01.2016
Quality Assurance Coordinator
BAPTIST HEALTH SYSTEM
01.2006 - 01.2010
Master of Business Administration -
Abilene Christian University
Bachelor of Science - undefined
Texas A&M University
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