Job Description
A critical role within the Quality Control group, this position is responsible for managing and supporting external testing activities in support of our quality program.
Key Responsibilities:
* Organizing and scheduling external testing to support product release and stability testing under cGMP
* Managing external data review per production schedule and stability program
* Coordinating investigation activities at contract laboratories to ensure thorough technical content and compliant documentation
* Communicating and soliciting input from Regeneron SMEs and Quality Assurance
* Authoring Master Service Agreements, as necessary
* Participating in GMP audits to the contract labs
* Coordinating and leading quarterly meetings between contract labs and QC management
Requirements:
* Current or prior experience working in a regulated environment
* Proven ability to work independently or as part of a team
* Strong trouble-shooting and problem-solving skills
BS/BA in Chemistry, Biology, or related field with 5+ years of experience in Laboratory Management and analytical testing and some previous supervisory/leadership experience. Relevant experience may be substituted for educational requirements.