Karen Rader

FAQ About Karen Rader

• What is Karen Rader's address?

  Karen Rader is located at
  Grayslake, Illinois, United States

• What is Karen Rader's job title?

  Karen Rader is a
  Analytical Specialties: Method validation including HPLC, UPLC, GC-HS, potentiometric titration, and wet chemistry. Control and validation of spreadsheets used for assay and impurity calculations. I have 18+ years experience auditing drug substance/API, Excipient, Clinical, CRO and CMO vendors Globally. Considered as a SME for aseptic manufacturing, cell banking, salt and heparin sodium APIs. Also developed subject matter expertise in auditing GLP facilities and Phase 0-IV Clinical Trials. Currently developing subject matter expertise in Gene Therapy Drug and vaccine Portfolios. Global CAPA owner for multiple medium and low risk Corrective Action and Preventive Actions. Other CAPA roles include initiator, investigation owner, action owner, and quality approver. I also have training in evaluating human performance factors for unplanned events. Familiar with Trackwise and Veeva Vault. Manage any Notification of Change for respective vendors/CMOs. Routinely author Quality Risk Management (QRM) reports and create mitigation plans based on risk. Provided input to decisions for and/or act as a Quality Person-in-Plant as needed. ASQ-CQA certified 2015-2016 President of Baxter Toastmaster Club #2447, District 30, Area 41 Pfizer

• What industry does Karen Rader currently work in?

  Karen Rader currently works in the
  Pfizer

• What is Karen Rader's area of expertise?

  Karen Rader specializes in
  Analytical Specialties: Method validation including HPLC, UPLC, GC-HS, potentiometric titration, and wet chemistry. Control and validation of spreadsheets used for assay and impurity calculations. I have 18+ years experience auditing drug substance/API, Excipient, Clinical, CRO and CMO vendors Globally. Considered as a SME for aseptic manufacturing, cell banking, salt and heparin sodium APIs. Also developed subject matter expertise in auditing GLP facilities and Phase 0-IV Clinical Trials. Currently developing subject matter expertise in Gene Therapy Drug and vaccine Portfolios. Global CAPA owner for multiple medium and low risk Corrective Action and Preventive Actions. Other CAPA roles include initiator, investigation owner, action owner, and quality approver. I also have training in evaluating human performance factors for unplanned events. Familiar with Trackwise and Veeva Vault. Manage any Notification of Change for respective vendors/CMOs. Routinely author Quality Risk Management (QRM) reports and create mitigation plans based on risk. Provided input to decisions for and/or act as a Quality Person-in-Plant as needed. ASQ-CQA certified 2015-2016 President of Baxter Toastmaster Club #2447, District 30, Area 41

• Which languages does Karen Rader speak? 

  Karen Rader speaks the following languages:
  No languages available.

• Which industries has Karen Rader previously worked in?   

  Karen Rader has prior experience in the following industries:
  Pfizer , Baxter International , Baxter Healthcare , Baxter Healthcare , Marquette University , Pharma Logistics

• What is Karen Rader’s work experience?  

  Karen Rader has the following professional experience:
  Pfizer , Baxter International , Baxter Healthcare , Baxter Healthcare , Marquette University , Pharma Logistics .

• How can I find Karen Rader on LinkedIn?  

  You can view Karen Rader’s
  LinkedIn profile at LinkedIn URL.

• What are Karen Rader’s work email addresses?  

  Karen Rader’s work email addresses are
  [email protected] .

• What company does Karen Rader work for?  

  Karen Rader works at
  Pfizer