Nonclinical Quality Control Reviewer II

Location: Lexington
Posted on: June 23, 2025

Job Description:

Payrate: $65.13 - $65.13/hr. Summary: 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. Responsibilities: 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 Qualifications: Minimum bachelor's degree in life science discipline 3 years’ experience in pharmaceutical/biotechnology environment Prior experience with quality control of data for scientific reports and regulatory submission content 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. Top 3 Must Haves: Experience with QC of nonclinical study documentation Familiarity with bioanalysis, pharmacokinetics, and pharmacology test systems and software Detail oriented with strong analytical skill set Pay Transparency: The typical base pay for this role across the U.S. is: $65.13 - $65.13/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance. For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy). Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.

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