Job Description

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 [email protected]

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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