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Quality Control Reviewer II
- Contract
- Good Clinical Practice (GCP)
- United States
This vacancy has now expired. Please see similar roles below...
Quality Control Reviewer II - Contract - Boulder, CO
Proclinical is seeking a Quality Control Reviewer II for a hybrid role in Boulder, CO.
Primary Responsibilities:
The successful candidate will be integral to ensuring the accuracy and compliance of nonclinical study documentation. This position requires collaboration with various teams to deliver submission-ready documents.
Skills & Requirements:
- Bachelor's degree in a life science discipline.
- Experience in pharmaceutical or biotechnology environments.
- Experience in quality control of scientific reports and regulatory submission content.
- Familiarity with FDA guidance and ICH guidelines.
- Strong attention to detail and organizational skills.
- Proficiency in written English and excellent communication skills.
- Proficiency with MS Office, GraphPad Prism, and lab-based analytical software.
The Quality Control Reviewer II's responsibilities will be:
- Conduct quality control reviews of raw data from the ADME team, including bioanalytical data from HPLC-FD and LC-MS/MS systems and qPCR.
- Verify data for accuracy, completeness, and compliance with internal guidelines.
- Collaborate with teams to resolve data inconsistencies.
- Provide QC review of reports and nonclinical regulatory content, ensuring adherence to internal procedures and FDA/ICH guidelines.
- Complete reviews within established timelines.
If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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