Quality Control Review Resource I

Quality Control Review Resource I  (GPV)

3 Months

Marlborough, MA

Max PR: $52.46/hr

Description:

• Conduct Quality Control (QC) review to ensure data integrity of CMC (non-GxP) Development studies intended for regulatory submissions.
• Responsibilities:
• Ensures integrity, accuracy and consistency of data and documents.
• Conducts quality assurance (QA) review, including verification of data against approved supporting documents/ sources of medical/scientific information for aggregate reports. Provides quality guidance to developmental personnel as required.

Qualifications:

• Excellent oral and written communication skills
• Experience in a pharmaceutical development environment with knowledge and review experience on development study protocols and reports for investigational stage products.
• Familiar with FDA regulations including Good Laboratory Practice (GLP) and current Good Manufacturing Practices (cGMP)
• Ability to exercise sound judgment and professionalism in all interactions.
• Ability to work with a high degree of accuracy and attention to detail.