TAYLOR KAETER
Elk Grove Village,IL
Summary
Quality and operations leader with nearly 18 years of progressive experience in plasma derived therapy services, regulatory compliance, and quality management. Known for elevating audit readiness, optimizing processes, and strengthening quality systems across high-volume, highly regulated environments. Skilled at interpreting complex regulations, leading cross-functional initiatives, and implementing systems that enhance accuracy, safety, and efficiency. Recognized for clear communication, decisive problem-solving, and a commitment to maintaining the highest standards of product quality and donor safety.
Overview
18
18
years of professional experience
Work History
Quality Coordinator
Takeda BioLife Plasma Services - Position Eliminated Due to Company Wide Reorganization
08.2022 - 07.2024
- Developed and implemented quality assurance protocols to ensure compliance with regulatory standards.
- Trained staff on best practices in quality control and safety procedures, enhancing overall team performance.
- Analyzed quality data to identify trends and recommend corrective actions for non-conformance issues.
- Collaborated with cross-functional teams to streamline processes and improve product quality consistency.
- Led initiatives to enhance operational efficiency, reducing waste and optimizing resource utilization.
- Collaborated with cross-functional teams to improve overall product performance and customer satisfaction rates.
- Analyzed data trends to identify opportunities for process improvements, leading to a more efficient workflow and higher quality output.
- Developed a culture of continuous improvement within the organization by encouraging team members to identify opportunities for enhancement and facilitating their efforts to implement those changes.
Senior Quality Assurance Specialist
Takeda BioLife Plasma Services
11.2016 - 08.2022
- Partnered with Global to help translate SOPs for non-global staff while still adhering to regulations.
- Led quality assurance initiatives ensuring compliance with regulatory standards and internal policies.
- Conducted internal audits to ensure adherence to policies, procedures, and regulatory expectations.
- Implemented corrective action plans addressing non-conformances, driving accountability across functional departments.
- Collaborated with cross-functional teams to resolve quality issues, promoting a culture of continuous improvement.
- Coordinated user acceptance testing (UAT) with business analysts and developers.
- Produced detailed QA reports with recommendations for corrective and preventive actions.
Quality Operations Analyst
Takeda BioLife Plasma Services
12.2015 - 11.2016
- Conducted data analysis to support tracking, trending, decision-making and strategic planning initiatives for over 230 sites
- Authored and revised SOPs, providing network-wide training to ensure consistent adoption of updated processes.
- Served as Business Process Owner for transitioning sensitive regulatory materials from paper to an electronic reporting system, improving accuracy and compliance.
- Originated and revised SOPs and trained network on changes.
- Managed multiple projects simultaneously, delivering results within tight deadlines while maintaining high-quality standards.
Quality Management Representative
BioLife Plasma Services
07.2015 - 11.2016
- Supported the opening of a new plasma center, achieving consecutive successful audits (PPTA, CLIA, PQAG, FDA, EMA).
- Developed training programs for staff on quality management systems and best practices.
- Ensured compliance with federal, state, local, and company-specific regulations.
- Assisted in developing and implementing quality management systems.
- Investigated nonconformances, identified root causes, and developed corrective action plans.
- Monitored the effectiveness of corrective actions to ensure sustained improvement.
Training Supervisor
BioLife Plasma Services
06.2013 - 07.2015
- Supported the opening of this new location responsible for the training of all employees.
- Developed, coached, and mentored employees to support skill development and performance improvement on equipment use, software applications and iterations and operational procedures.
- Led the transition between Learning Management Systems (iSOtrain to SABA), ensuring continuity and training accuracy.
- Conducted regular performance evaluations to identify areas for improvement in team skills and knowledge.
Center Supervisor
BioLife Plasma Services
09.2011 - 06.2013
- Ran the production floor for all processing areas.
- Provided leadership, coaching, and training to center staff.
- Ensured compliance with operational and quality standards.
- Supervised daily operations to ensure compliance with safety and quality standards.
Master Plasma Center Technician
BioLife Plasma Services
05.2009 - 09.2011
- Performed daily maintenance on centrifuges and laboratory equipment.
- Monitored inventory levels to maintain adequate supplies for efficient center function.
- Contributed to continuous improvement efforts through participation in staff meetings, trainings, and workshops.
Center Line Staff
BioLife Plasma Services
07.2006 - 05.2009
- Conducted routine plasma collection procedures ensuring adherence to safety protocols.
- Supported development and implementation of staff policies and procedures.
- Assisted with equipment maintenance and calibration to optimize operational efficiency.
- Trained new staff on best practices for donor care and plasma processing.
Education
Bachelor of Science -
St. Cloud State University
St. Cloud, MNSkills
- Quality & Compliance
- Quality Management Systems (QMS)
- FDA/EMA/EMA/CLIA/PPTA Compliance
- Internal Auditing
- Audit Readiness
- CAPA & Deviation Management
- Document Control
- Risk Assessment
- Operations & Process Improvement
- Operational Excellence
- Process Optimization
- Data Analysis & Reporting
- Root Cause Investigation
- SOP Development
- SharePoint Administration
- TrackWise SME (Change Control, Supplier Management)
- Leadership & Collaboration
- Training & Development
- Team Leadership
- Cross-Functional Communication
- Stakeholder Engagement
- Customer Service
- Relationship Building
- Technical Skills
- Visual Inspections
- Laboratory Equipment Maintenance
- UAT Coordination
Accomplishments
- Reported Viral Marker Data monthly to PPTA per regulatory requirements
- Managed multiple SharePoint sites supporting quality and operations
- Achieved paperless tracking and trending by introducing digital (SharePoint, TrackWise and other electronic systems for accuracy and real time metrics for continuous improvements.
- Contributed to a cross-functional team that won a global company-wide initiative
CORE STRENGTHS
- Detail-oriented operations and quality professional known for strengthening processes, improving documentation, and driving continuous improvement across regulated environments. Experienced in leading teams, collaborating with third-party vendors, and supporting initiatives that enhance product reliability and operational efficiency.
- Recognized for a practical, solutions-focused approach that elevates performance, ensures compliance, and supports strong organizational outcomes.
Timeline
Quality Coordinator
Takeda BioLife Plasma Services - Position Eliminated Due to Company Wide Reorganization
08.2022 - 07.2024
Senior Quality Assurance Specialist
Takeda BioLife Plasma Services
11.2016 - 08.2022
Quality Operations Analyst
Takeda BioLife Plasma Services
12.2015 - 11.2016
Quality Management Representative
BioLife Plasma Services
07.2015 - 11.2016
Training Supervisor
BioLife Plasma Services
06.2013 - 07.2015
Center Supervisor
BioLife Plasma Services
09.2011 - 06.2013
Master Plasma Center Technician
BioLife Plasma Services
05.2009 - 09.2011
Center Line Staff
BioLife Plasma Services
07.2006 - 05.2009
Bachelor of Science -
St. Cloud State University