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, MNTimeline
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
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