Quality Control Reviewer

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!