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Job type: Contract

Discipline: Good Clinical Practice (GCP)

Location: United States

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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