Quality Control Reviewer II Job at Proclinical Staffing, Boulder, CO

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  • Proclinical Staffing
  • Boulder, CO

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 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.

Job Tags

Contract work,

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