Quality Specialist, Small Molecules - job 1 of 2

Job Summary

A company is looking for a Sr Specialist, External Quality Small Molecules.

Key Responsibilities:

• Provide quality support for external manufacturing sites and ensure effective execution of quality systems
• Support quality oversight in the qualification and monitoring of external partners and resolve quality issues
• Review and approve quality systems documentation and monitor quality performance through key performance indicators

Qualifications:

• A minimum of a Bachelor's degree in life science, engineering, or physical science is required
• At least 8 years of experience in a cGMP regulated environment for Manager Level or 5 years for Sr Specialist Level
• Experience in quality oversight for pharmaceutical production and cGMP compliance
• Ability to work independently and on cross-functional project teams
• Preferred experience with external partners and product transfer initiatives