Senior Quality Specialist

Job Summary

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

Key Responsibilities:

• Provide quality support for effective execution of quality systems at external manufacturing sites
• Support quality oversight in the qualification and ongoing monitoring of external partners
• Review and approve quality systems documentation, assess change controls, 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
• A minimum of 8 years of experience in a cGMP regulated environment for Manager Level or 5 years for Sr Specialist Level
• Experience in supporting quality oversight for pharmaceutical production and cGMP compliance
• Ability to work independently and on cross-functional project teams
• Experience with external partners and product transfer is preferred