Overview
Work History
Education
Timeline
Generic

Taylor Kaeter

Elk Grove Village,IL

Overview

18
18
years of professional experience

Work History

Marker, Quality Coordinator

Takeda BioLife Plasma Services
Bannockburn, IL
08.2022 - 07.2024
  • Nearly 18 years of BioLife / Takeda company experience
  • Reported Viral, Data monthly to PPTA per Regulations
  • Responsible for multiple SharePoint sites
  • Projects & Support:
  • Internal Audit Team Member
  • Supplier Management Support for backlog
  • TrackWise SME for Deviation and CAPA
  • Lead initiative to transfer minor level errors from SharePoint to TrackWise
  • Well trained in TrackWise for Change Control and Supplier Management
  • Regulatory Affairs Support - BPDR
  • Lookback Support - PDIR (Post Donation Information Reporting, Plan and direct administrative, financial, and Quality activities for the BioLife
  • Organization
  • Organize and prioritize critical issues and required information for the Global Head of
  • Quality of BioLife to facilitate efficient decision making
  • Act as a point of contact between top management and other stakeholders, as a trusted advisor to the senior leadership team

Marker, Quality Coordinator

Takeda BioLife Plasma Services
Bannockburn, IL
08.2022 - 07.2024
  • Nearly 18 years of BioLife / Takeda company experience
  • Reported Viral, Data monthly to PPTA per Regulations
  • Responsible for multiple SharePoint sites
  • Projects & Support:
  • Internal Audit Team Member
  • Supplier Management Support for backlog
  • TrackWise SME for Deviation and CAPA
  • Lead initiative to transfer minor level errors from SharePoint to TrackWise
  • Well trained in TrackWise for Change Control and Supplier Management
  • Regulatory Affairs Support - BPDR
  • Lookback Support - PDIR (Post Donation Information Reporting, Plan and direct administrative, financial, and Quality activities for the BioLife
  • Organization
  • Organize and prioritize critical issues and required information for the Global Head of
  • Quality of BioLife to facilitate efficient decision making
  • Act as a point of contact between top management and other stakeholders, as a trusted advisor to the senior leadership team

Senior Quality Assurance Specialist

Takeda BioLife Plasma Services
Bannockburn, IL
11.2016 - 08.2022
  • Responsible for providing Quality support and oversight via indirect staff supervision or process / area responsibilities
  • Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and quality practices

Senior Quality Assurance Specialist

Takeda BioLife Plasma Services
Bannockburn, IL
11.2016 - 08.2022
  • Responsible for providing Quality support and oversight via indirect staff supervision or process / area responsibilities
  • Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and quality practices

Quality Management Representative

BioLife Plasma Services
Maple Grove, MN
07.2015 - 11.2016
  • Opened a new plasma donation center with consecutive successful audits and inspections (PPTA, CLIA, PQAG (internal Plasma Quality Audit Group), FDA & EMA)
  • Ensured center compliance with all federal, state, local and company-specific regulations related to quality of product, employee, and donor safety

Quality Management Representative

BioLife Plasma Services
Maple Grove, MN
07.2015 - 11.2016
  • Opened a new plasma donation center with consecutive successful audits and inspections (PPTA, CLIA, PQAG (internal Plasma Quality Audit Group), FDA & EMA)
  • Ensured center compliance with all federal, state, local and company-specific regulations related to quality of product, employee, and donor safety

Training Supervisor

BioLife Plasma Services
Waite Park, MN
06.2013 - 07.2015
  • Develop and mentor employees to help them achieve their goals
  • Transitioned Learning Management Systems (iSOtrain to SABA)

Training Supervisor

BioLife Plasma Services
Waite Park, MN
06.2013 - 07.2015
  • Develop and mentor employees to help them achieve their goals
  • Transitioned Learning Management Systems (iSOtrain to SABA)

Center Supervisor

BioLife Plasma Services
St. Cloud, MN
09.2011 - 06.2013
  • Responsible for all job duties associated with the screening, processing, and sample collection for new and repeat donors, as well as center leadership and training

Center Supervisor

BioLife Plasma Services
St. Cloud, MN
09.2011 - 06.2013
  • Responsible for all job duties associated with the screening, processing, and sample collection for new and repeat donors, as well as center leadership and training

Master Plasma Center Technician

BioLife Plasma Services
St. Cloud, MN
05.2009 - 10.2016
  • A member of the Quality Committee; worked with Quality Management Representative and a team to find ways to lower center non-conforming events by event area or regulatory reference

Master Plasma Center Technician

BioLife Plasma Services
St. Cloud, MN
05.2009 - 10.2016
  • A member of the Quality Committee; worked with Quality Management Representative and a team to find ways to lower center non-conforming events by event area or regulatory reference

Center Line Staff

BioLife Plasma Services
St. Cloud, MN
07.2006 - 05.2009

Center Line Staff

BioLife Plasma Services
St. Cloud, MN
07.2006 - 05.2009

Education

Bachelor of Science -

St. Cloud State University
St. Cloud, MN

Timeline

Marker, Quality Coordinator

Takeda BioLife Plasma Services
08.2022 - 07.2024

Marker, Quality Coordinator

Takeda BioLife Plasma Services
08.2022 - 07.2024

Senior Quality Assurance Specialist

Takeda BioLife Plasma Services
11.2016 - 08.2022

Senior Quality Assurance Specialist

Takeda BioLife Plasma Services
11.2016 - 08.2022

Quality Management Representative

BioLife Plasma Services
07.2015 - 11.2016

Quality Management Representative

BioLife Plasma Services
07.2015 - 11.2016

Training Supervisor

BioLife Plasma Services
06.2013 - 07.2015

Training Supervisor

BioLife Plasma Services
06.2013 - 07.2015

Center Supervisor

BioLife Plasma Services
09.2011 - 06.2013

Center Supervisor

BioLife Plasma Services
09.2011 - 06.2013

Master Plasma Center Technician

BioLife Plasma Services
05.2009 - 10.2016

Master Plasma Center Technician

BioLife Plasma Services
05.2009 - 10.2016

Center Line Staff

BioLife Plasma Services
07.2006 - 05.2009

Center Line Staff

BioLife Plasma Services
07.2006 - 05.2009

Bachelor of Science -

St. Cloud State University
Taylor Kaeter