Taylor Kaeter
Elk Grove Village,USA
Summary
Results-driven Quality Coordinator with nearly 18 years at global Bio-tech company in the Plasma Derived Therapies business unit. I have expertise in Quality Management Systems and internal auditing. Skilled in data analysis and fostering cross-functional communication, I excel at implementing corrective actions and enhancing compliance, ensuring product reliability and customer satisfaction. Proven track record in stakeholder engagement and strategic planning.
Overview
18
18
years of professional experience
Work History
QUALITY COORDINATOR
Takeda BioLife Plasma Services
08.2022 - 07.2024
- Coordinated with FDA and other regulatory agencies during routine inspections and special investigations.
- Ensured accuracy and completeness of documentation in alignment with company policies and regulatory requirements.
- Delivered updates to management on quality trends, audit findings, and ongoing initiatives.
- Prepared detailed reports summarizing inspection outcomes, investigations, and audit activities.
- Analyzed laboratory data for accuracy and completeness prior to product release.
- Maintained comprehensive records of QA/QC activities, test results, and compliance documentation.
- Bannockburn, USA
SENIOR QUALITY ASSURANCE SPECIALIST
Takeda BioLife Plasma Services
11.2016 - 08.2022
- Developed and implemented QA standards to strengthen product safety and reliability.
- Conducted internal audits to ensure adherence to policies, procedures, and regulatory expectations.
- Partnered with cross-functional teams to troubleshoot issues and recommend corrective actions.
- Part of a multi-operational unit team for a large scale investigation impacting start to finish product.
- Assessed training needs and delivered targeted training to improve quality performance.
- Coordinated user acceptance testing (UAT) with business analysts and developers.
- Produced detailed QA reports with recommendations for corrective and preventive actions.
- Authored automated testing scripts and established performance metrics to evaluate QA effectiveness.
- Bannockburn, USA
Quality Operations Analyst
Takeda BioLife Plasma Services
11.2016 - 06.2019
- Reviewed data and conducted data analysis to detect gaps, inconsistencies and errors.
- Developed key metrics for operational and financial tracking and optimization.
- Analyzed range of possible solutions and presented findings to leadership.
- Collected data from various internal sources to prepare and maintain analytical reports.
- Transformed tracking and trending of minor non-conformances to cast a wider net on larger issues.
QUALITY MANAGEMENT REPRESENTATIVE
BioLife Plasma Services (Baxalta / Shire)
07.2015 - 11.2016
- Supported the opening of a new plasma center, achieving consecutive successful audits (PPTA, CLIA, PQAG, FDA, EMA).
- Ensured compliance with federal, state, local, and company-specific regulations.
- Assisted in developing and implementing quality management systems.
- Reviewed customer requirements to ensure regulatory alignment.
- Investigated nonconformances, identified root causes, and developed corrective action plans.
- Monitored the effectiveness of corrective actions to ensure sustained improvement.
- Maple Grove, USA
MASTER PLASMA CENTER TECHNICIAN
BioLife Plasma Services (Baxter / Baxalta)
05.2009 - 10.2016
- Performed daily maintenance on centrifuges and laboratory equipment.
- Assisted with plasma collection and ensured accurate donor documentation.
- Provided basic medical support to donors during the donation process.
- Educated donors on safe and responsible plasma donation practices.
TRAINING SUPERVISOR
BioLife Plasma Services (Baxalta)
06.2013 - 07.2015
- Conducted performance assessments to identify training needs.
- Delivered training on equipment use, software applications, and operational procedures.
- Supported onboarding by preparing orientation materials and guiding new hires.
- Developed and implemented training programs for new employees.
- Led the transition between Learning Management Systems.
CENTER SUPERVISOR
BioLife Plasma (Baxter)
09.2011 - 06.2013
- Provided leadership, coaching, and training to center staff.
- Ensured compliance with operational and quality standards.
- Observed team performance to provide feedback to management for discipline and performance evaluations.
- Coordinated employee schedules according to availability and assisted with shift coverage.
- Assigned tasks to team members based on individual strengths and promoted teamwork-driven environment to meet goals.
CENTER LINE STAFF
BioLife Plasma Services (Baxter)
07.2006 - 05.2009
- Supported development and implementation of staff policies and procedures.
- Assisted management with recruitment, training, performance reviews, and disciplinary actions.
- Contributed to customer service improvement initiatives.
- Helped plan special events and promotional activities.
Education
Bachelor of Science - Sociology
St. Cloud State University
St. Cloud, MN05.2011
Skills
- QUALITY MANAGEMENT SYSTEMS (QMS)
- INTERNAL AUDITING AND EXTERNAL AUDITING HOST
- TRACKWISE SUBJECT MATTER EXPERT
- DEVIATION AND CAPA MANAGEMENT
- DOCUMENT CONTROL
- CHANGE CONTROL
- ACTIVE LISTENER
- OPERATIONAL EXCELLENCE
- DATA ANALYSIS, REPORTING, PREPARING AND PRESENTING DATA WITH PROPOSED SOLUTIONS
- DEVELOPMENT, AUTHOR, EDITOR AND APPROVER OF SOPS
- SELF - AWARENESS
- EMOTIONAL INTELLIGENCE
- SHAREPOINT ADMINISTRATION
- CROSS-FUNCTIONAL COMMUNICATION
- STAKEHOLDER ENGAGEMENT
- RELATIONSHIP BUILDING
- POLICY AND PROCEDURE IMPLEMENTATION
- TRAINING AND DEVELOPMENT
- CUSTOMER SATISFACTION
- STRATEGIC PLANNING
- CHANGE CONTROL PROCEDURES
- CRITICAL THINKING SKILLS
- TRACKWISE EXPERTISE
- TEAM LEADERSHIP
- CROSS-FUNCTIONAL
- COMMUNICATION
- CUSTOMER SERVICE
- VISUAL INSPECTIONS
- LABORATORY EQUIPMENT MAINTENANCE
- UAT COORDINATION
- AUTOMATED TESTING SCRIPTS
Accomplishments
- Nearly 18 years experience in the highly regulated Bio-Tech industry from end to end processing
- Supported the transition of the Document Management System and Deviation and CAPA workflow for the entire network of over 10,000 employees
- Reported viral sensitive viral marker Data monthly to PPTA per regulatory requirements
- Managed multiple SharePoint sites supporting quality and operations
- Contributed to a cross-functional team that won a company-wide global initiative
Timeline
QUALITY COORDINATOR
Takeda BioLife Plasma Services
08.2022 - 07.2024
SENIOR QUALITY ASSURANCE SPECIALIST
Takeda BioLife Plasma Services
11.2016 - 08.2022
Quality Operations Analyst
Takeda BioLife Plasma Services
11.2016 - 06.2019
QUALITY MANAGEMENT REPRESENTATIVE
BioLife Plasma Services (Baxalta / Shire)
07.2015 - 11.2016
TRAINING SUPERVISOR
BioLife Plasma Services (Baxalta)
06.2013 - 07.2015
CENTER SUPERVISOR
BioLife Plasma (Baxter)
09.2011 - 06.2013
MASTER PLASMA CENTER TECHNICIAN
BioLife Plasma Services (Baxter / Baxalta)
05.2009 - 10.2016
CENTER LINE STAFF
BioLife Plasma Services (Baxter)
07.2006 - 05.2009
Bachelor of Science - Sociology
St. Cloud State University
AWARDS
Part of a Global team effort for a large research project during the pandemic that was recognized by the CEO