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
Registered Nurse- Medical Support specialist at BioLife Plasma Services, Takeda PharmaceuticalsRegistered Nurse- Medical Support specialist at BioLife Plasma Services, Takeda Pharmaceuticals