Senior Quality Specialist

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

Jun 25, 2025 - 14:40
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Senior Quality Specialist
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