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Quality Control Reviewer

Careers Integrated Resources Inc
Boulder, CO Full Time
POSTED ON 3/11/2025
AVAILABLE BEFORE 6/6/2025

Job Title : Quality Control Reviewer

Location : Boulder, CO

Duration : 9 months

Pay Range : $ 60.48 / hr. on w2

Top 3 must have :

  • Experience with QC of nonclinical study documentation
  • Familiarity with bioanalysis, pharmacokinetics, and pharmacology test systems and software
  • Detail oriented with strong analytical skill set

Purpose / job description :

This position will work closely with nonclinical medical writing, toxicology, bioanalytical, pharmacology, and research teams to conduct QC activities to support delivery of accurate, compliant, and submission-ready documents, including study reports and regulatory summaries.

Essential functions :

  • 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 of established timelines

    • Salary : $60

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