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Quality Control Reviewer

Quality Control Reviewer

Tap Growth aiBoulder, Colorado, US
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We're Hiring : Quality Control Reviewer! 🌟

We are seeking a detail-oriented and experienced Quality Control Reviewer to ensure our products and processes meet the highest standards. The ideal candidate will have a keen eye for detail, strong analytical skills, and the ability to identify issues before they impact our customers.

Location : Boulder, CO

What You'll Do :

  • Perform QC review of raw data generated by ADME team, including bioanalytical data generated by HPLC-FD and LC-MS / MS systems and qPCR​
  • Verify data for accuracy, completeness, and compliance with internal guidelines​
  • Work with team to resolve inconsistencies​
  • Work closely with nonclinical writing team to provide QC review of reports and nonclinical regulatory content; ensure final documents adhere to internal procedures as well as FDA / ICH guidelines​
  • Complete reviews per established timelines

What We're Looking For :

  • Minimum bachelors degree in life science discipline​
  • 3+ years experience in pharmaceutical / biotechnology environment​
  • Experience with QC of nonclinical study documentation
  • Prior experience with quality control of data for scientific reports and regulatory submission content​
  • Familiarity with bioanalysis, pharmacokinetics, and pharmacology test systems and software​
  • Familiarity with FDA guidance and ICH guidelines preferred​
  • Critical attention to detail and strong organizational skills​
  • High degree of fluency with written English​
  • Excellent communication and interpersonal skills​
  • Proficiency with MS office (word, excel), GraphPad Prism, and understanding of lab-based analytical software
  • Detail oriented with strong analytical skill set​
  • Ready to ensure excellence? 🚀 Apply now and help us maintain our quality standards!

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    Quality Control • Boulder, Colorado, US