Job Summary

A company that provides regulatory, scientific, and management consulting services to healthcare product companies is searching for a person to fill their position for a Remote Quality Assurance Consultant.

Core Responsibilities Include:

• Provide Quality Assurance oversight of client CMC development programs
• Maintain vendor regulatory compliance documentation
• Execute GMP vendor qualification audits and mock-PAIs/PLIs

Skills and Requirements Include:

• Bachelor’s degree, if possible in a scientific field (e.g., biology, chemistry, biochemistry, etc.), is required
• Consulting experience and RQAP certification are desired
• A minimum of 6-8 years in the pharmaceutical/biotechnology industry and/or consulting
• At least 4 years in Quality Assurance relating to the oversight of CMC development
• Excellent understanding of pharmaceutical regulations
• Excellent written and verbal communication skills