What are the responsibilities and job description for the Non Clinical Quality Control Reviewer II position at GForce Life Sciences?
Non-Clinical Quality Control Reviewer II
On-site in Lexington, MA
Must be able to work on a W2
TOP 3 MUST HAVES:
1. Experience with QC of nonclinical study documentation
2. Familiarity with bioanalysis, pharmacokinetics, and pharmacology test systems and software
3. 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 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 con-tent
- 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.
