Job Description

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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