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QC Data Reviewer

Organization
Aldevron
Job Location
Fargo
Fargo, ND 58104
United States
Job Description

We are seeking a QC Data Reviewer to join our team! The QC Data Reviewer will provide data review and reporting for in-process, release, stability, EM, CoA, summary reports, method qualification and method transfer testing activities. This position is a non-lab based position and in this role, this individual will review data for accuracy and compliance to applicable Standard Operating Procedures (SOPs), protocols, and regulatory guidelines. 

About this Role:

  • Evaluates data to ensure compliance with methods, client criteria, Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
  • Perform detailed data review for test results on assays such as ELISA, DNA/RNA extraction and gel electrophoresis, PCR, HPLC, Capillary Electrophoresis, Bioburden, Endotoxin, etc. 
  • Reviews sample results tables and analytical reports for completeness and accurate representation of the data and report findings
  • Prepare QC statements noting deficiences with the analytical data set or notebooks
  • Communicate with laboratory staff to proactively address the quality of laboratory documentation
  • Utilize the electronic files and reporting systems for review of complied data and manual entry
  • Respond to QA inspection report findings related to QC review of data
  • Participate in investigations for OOS/OOT results and Unplanned Events (deviations) 
  • Work cross-functionally with QA, Assay Validation, and Manufacturing to drive closure of quality systems items 
  • Consults with supervisor regarding priority assignments 
Requirements

About You:

  • BA/BS degree in Biology, Chemistry, Microbiology or related experience
  • 0-2 years of recent professional experience in a QC lab
  • Experience in reviewing testing data

Why Join Aldevron? 

  • You want meaningful work.  We are in a landmark moment in the history of life science, and Aldevron is at the center of it.  
  • You want to plant your career in a growing company.  We are growing fast.  We have limitless opportunities for people who are ready to roll up their sleeves and jump in. 
  • You are excited to learn every day.  At Aldevron, no day is the same.  Our team comes to work ready to learn and overcome new challenges with teamwork and a passion to make lives better.   

Your talents, ideas, and passion are essential to our success.  Join us today! 


How to Apply

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://www.applicantpro.com/j/1172451-149639

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