Jason Priest
Yorktown,IN
Summary
Methodical Quality Assurance Manager with superb problem-solving and analytical abilities. Specialties include continuous improvement, program implementation and documentation. Committed to thoroughly assessing product quality and manufacturing processes to adhere to GMP, GxP, and Regulatory standards.
Overview
13
13
years of professional experience
Work History
Quality Management Representative
Biolife Plasma Services
03.2016 - Current
- Completed multiple successful FDA, AGES (EMA), IQPP, State Health, and CLIA audits. No 483 or major/critical findings ever noted.
- Responsible for all systems that influence donor safety and plasma purity
- Review all documentation to ensure compliance with cGMP and FDA regulations.
- Assist in the creation and implementation of CAPAs to help prevent/reduce center deviation-level error's.
- Determined quality department standards, practices and procedures.
- Trained employees in SOPs, Regulatory Standards, Quality Systems, best practices, and company metrics.
Advanced Plasma Care Technician/Quality Lead Technician
Biolife Plasma Services
08.2011 - 03.2016
- Educated patients about procedures, answered questions and provided comforting words to control anxiety and enhance procedure results.
- Documented observations and baseline measurements in medical records.
- Adhered to strict infection control measures and verified proper cleaning and sanitation of equipment prior to each use.
- Checked patient identifying information against records to uphold strict security, safety and regulatory standards.
Skills
- Knowledge of quality systems
- Staff training and development
- Quality control tests
- Attention to Detail
- Self-Motivated
- Analytical and Critical Thinking
Accomplishments
Adherence to standards leading to successful audits from all external Regulatory agencies - FDA, EMA, State Department of Health, IQPP, and CLIA.
Creation and implementation of Individual Development Plans as mentor, leading to three individuals promoted to leadership positions within the network.
Maintained results in all Quality metrics through root-cause analysis and effective CAPAs, utilizing Six Sigma capabilities.
Timeline
Quality Management Representative
Biolife Plasma Services
03.2016 - Current
Advanced Plasma Care Technician/Quality Lead Technician
Biolife Plasma Services
08.2011 - 03.2016