Faustina Craft
Summary
Experienced professional with a strong background in guiding teams, managing complex projects, and achieving strategic objectives. Excels in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for a collaborative approach and commitment to excellence. Specializes in medical technology, laboratory operations, training, data management, pharmacovigilance, and quality. Recognized for optimizing procedures, improving training programs, and enhancing patient outcomes. Demonstrates strong analytical skills and a collaborative spirit, coordinating with multidisciplinary teams to streamline processes and improve efficiency.
Overview
28
28
years of professional experience
Work History
Medical Technologist
Waterbury Hospital
01.2023 - Current
- Optimizes procedures, achieving measurable improvements in lab turnaround times.
- Adheres to safety protocols, ensuring high standards in quality control.
- Serves on Waterbury Hospital's Infection Control Committee.
- Serves as Point of Care backup, facilitating device training, competency, maintenance checks, and quality assurances.
- Provides hands-on patient care testing for immunohematology and hematology.
- Dispenses packed red blood cells, platelets, fresh frozen plasma, cryoprecipitate and other products as needed.
- Provides on the job training for current and new employees on immunohematology and hematology testing, devices, instruments, and procedures.
- Uses HealthStream and Media Lab as training and documentation tools.
- Contributes to the overall success of the laboratory by maintaining a positive attitude and demonstrating strong teamwork skills in daily interactions with peers.
- Follows laboratory protocols for specimen processing, analysis, and results reporting.
Quality Associate II
American Red Cross
10.2020 - 12.2022
- Resolved product issues to enhance product quality and ensure regulatory compliance.
- Orchestrated regulatory-compliant audits, facilitating efficient inspections.
- Enhanced team competencies through the implementation of standard-based training programs
- Applied quality methodologies, including Cause and Effect Analyses, CAPAs, Six Sigma principles, and PowerBi data visualization.
- Monitored risks and proactively mitigated them using KPI/KQI metrics.
- Utilized Master Control as a comprehensive quality management system for documentation of SOPs, safety protocols, actions, and resolutions.
- Trained, mentored and enhanced competencies of staff in regards to quality principles and regulatory requirements of immunohematology products.
- Contributed to successful ISO certification renewals by maintaining up-to-date documentation and demonstrating compliance during external audits.
- Maintained accurate records of all quality-related activities, ensuring compliance with regulatory requirements.
- Maintained open lines of communication with regulatory agencies, ensuring the organization remained in compliance with all applicable standards and industry regulations.
- Championed Lean Six Sigma initiatives within the department, driving waste reduction efforts through process optimization and standardization techniques.
- Conducted thorough root cause analyses for non-conformances, contributing to continuous improvement initiatives.
- Implemented process improvements based on data analysis, resulting in reduced defect rates and increased overall product quality.
- Developed comprehensive reports detailing quality metrics, trends, and recommendations for management review.
- Streamlined quality control procedures by developing and implementing standardized checklists for consistent inspections.
- Participated in internal audits to identify areas for improvement and ensure adherence to established procedures.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
COVID-19 Safety Associate - Consultant (Remote)
Jackson Laboratory
04.2019 - 12.2022
- Produced clinical plans to enhance the efficiency, efficacy and accuracy of COVID-19 testing and vaccine analysis.
- Executed case processing activities, including triage, data entry, case evaluations, narratives, and report distribution as required.
- Established quality standards to ensure regulatory compliance, timelines and submissions.
- Ensured all data submitted was consistent with protocols and regulatory standards.
Clinical Trial Toxicology Manager
ACM Global
01.2017 - 08.2021
- Directed toxicology phase I-IV trials, overseeing processes from site start-up to final regulatory submissions.
- Guaranteed compliance with global and local regulatory requirements by meticulously collecting and reporting adverse events from spontaneous cases, solicited cases, studies, and programs.
- Fostered cross-functional collaboration to ensure timely and accurate regulatory submissions with health authorities.
- Formulated CRFs, data management programs, INDs, IRB submissions, protocols, regulatory binders, safety reports, study reports, and other necessary clinical/regulatory documentation.
Program Compliance Manager - Consultant (Remote)
Western Connecticut Health Network
02.2018 - 04.2020
- Conducted comprehensive reviews (daily, monthly, quarterly, and annually) to monitor compliance with existing rules and regulations.
- Developed effective compliance strategies, data management systems and programs to align with state and federal laws.
- Evaluated team members' understanding of policies and educated them on relevant work-related laws and regulations.
- Identified and assessed potential compliance risks, subsequently formulating plans to mitigate or eliminate them.
- Trained and mentored quality assurance, teams and operations staff on quality principles and regulatory requirements of immunohematology, medical devices, and other laboratory testing.
Quality Analyst Consultant
Dianon Pathology
01.2016 - 07.2017
Epic Credentialed Trainer
St. Francis Hospital
07.2013 - 04.2016
Point of Care Coordinator
Connecticut Children's Medical Center
04.2014 - 10.2015
Chief Technologist of Hematology and Coagulation
Charlotte Hungerford Hospital
05.2002 - 07.2013
Pharmacovigilance/Drug Trial Manager
Boehringer Ingelheim Pharmaceutical
01.1997 - 05.2002
Education
Master of Science - Management and Biomedical Technology
Salve Regina University
Newport, RI05.1995
Bachelor of Science - Medical Technology
BRISMET
Providence, RI05.1990
Bachelor of Science - Biology
Salve Regina University
Newport, RI05.1989
Skills
- Analytical skills
- Argis
- Argus
- Audit Readiness
- Catalyst
- Collaboration
- Data Control/Management
- Education
- EPIC
- HealthStream
- Laboratory Operations
- Leadership
- Master Control
- Media Lab
- Mentoring
- Microsoft Office
- Pharmacovigilance
- PowerBi
- Quality Assurance
- Quality Control
- Quality Improvement
- Process optimization
- Problem solving
- Regulatory Compliance
- Risk Management
- Safety
- Technical and SOP writing
- Training
Timeline
Medical Technologist
Waterbury Hospital
01.2023 - Current
Quality Associate II
American Red Cross
10.2020 - 12.2022
COVID-19 Safety Associate - Consultant (Remote)
Jackson Laboratory
04.2019 - 12.2022
Program Compliance Manager - Consultant (Remote)
Western Connecticut Health Network
02.2018 - 04.2020
Clinical Trial Toxicology Manager
ACM Global
01.2017 - 08.2021
Quality Analyst Consultant
Dianon Pathology
01.2016 - 07.2017
Point of Care Coordinator
Connecticut Children's Medical Center
04.2014 - 10.2015
Epic Credentialed Trainer
St. Francis Hospital
07.2013 - 04.2016
Chief Technologist of Hematology and Coagulation
Charlotte Hungerford Hospital
05.2002 - 07.2013
Pharmacovigilance/Drug Trial Manager
Boehringer Ingelheim Pharmaceutical
01.1997 - 05.2002
Bachelor of Science - Medical Technology
BRISMET
Bachelor of Science - Biology
Salve Regina University
Master of Science - Management and Biomedical Technology
Salve Regina University
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