Kathy Wheeler

Experience

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  University of Toledo Medical Center

  Apr 1990 - Jul 1992

  Laboratory Technologist - Blood Bank and Generalist
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  St. Louis University Hospital

  Jul 1992 - Dec 1996

  Laboratory Technologist - Blood Bank
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  American Red Cross

  Apr 1995 - Aug 2015

  Manage Quality Assurance staff in Detroit and Lansing, MIHost external inspections (i.e. FDA, AABB, Customer Supplier Auditors, etc)Provide consultation and interpretation of quality standards Oversee internal audit programDevelop and manage projects and plansOversee/approve process improvement activities/corrective action plans/inspection responses Oversee/perform Quality Metrics analysis and reportingOversee/approve validation protocols, procedures, change control Show less Manage Quality Assurance staff in Detroit, MI and Philadelphia, PAHost external inspections (i.e. FDA, EU, NY state, Customer Supplier Auditors, etc)Oversee clinical trials for new assays and laboratory instruments to obtain FDA licensureOversee internal audit programDevelop and manage projects and plansOversee/perform Quality Metrics analysis and reportingOversee/approve process improvement activities/corrective action plans Oversee/approve validation protocols, procedures, change controlTrain curriculum associated with GMP and Quality ManagementProvide consultation and interpretation of quality standards Show less

  • Director, Quality

    Jan 2014 - Aug 2015

  • Director, Quality

    May 2003 - Jan 2014

  • Director, Quality Systems and Support

    Jan 2001 - May 2003

  • Laboratory Production Manager

    Aug 1999 - Dec 2000

  • Supervisor, Hospital Services/Quarantine and Labeling Lab

    Oct 1997 - Aug 1999

  • Reference Laboratory Technologist

    Dec 1996 - Oct 1997

  • Reference Laboratory Technologist

    Apr 1995 - Dec 1996
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  Detroit Medical Center

  Sept 2015 - Aug 2021

  Director, Quality and Compliance

  Manage Quality/Compliance Program for Laboratory System consisting of 12 CLIA licenses in 9 sitesProvide consultation and interpretation laboratory practices to regulatory standardsDevelop/Implement/Standardize Quality SystemsLead Process Improvement InitiativesManage internal audit programManage document control systemOversee management of non-conforming eventsOversee/perform Quality Metrics analysis and reportingHost external inspections (i.e. CAP, FDA, AABB) Show less

• 

  PathGroup

  Aug 2021 - now

  Quality Assurance Operations Director

  Oversee the Corporate Quality & Safety Program for 59 CLIA sites.Lead the Development/Implementation of policies that support the Corporate Quality & Safety Program.Implemented a standardized Document Control System using MediaLab.Developed/implemented electronic reporting system non-conforming events using MediaLab IQEDeveloped/implemented a tracking system to monitor Laboratory Licenses and External Audit due dates.Developed/Implemented Quality Dashboard to track key metrics that support Customer Service and Regulatory goals.Developed/Implemented a review process of patient reports to improve MIPS score to receive positive reimbursement.Developed/Implemented a Regulatory Assessment Review tool to assess new acquisitions compliance to external auditing agency regulations.Developed Internal Corporate Quality Audit program.Host external inspections (i.e. CAP, TN State, FDA). Show less