The Quality Control Specialist will oversee and support external testing activities within the Quality Control group to ensure compliance with the company's quality program.
A typical day may include:
* Scheduling External Testing: Organizing and scheduling external testing to support product release and stability testing under cGMP.
* Data Review: Managing external data review per production schedule and stability program.
* Contract Laboratory Management: Performing the single point of contact role with contract laboratory facilities, evaluating and monitoring their performance.
* Investigation Coordination: Coordinating investigation activities at contract laboratories to ensure thorough technical content and compliant documentation.
* Communication and Collaboration: Communicating and soliciting input from Regeneron SME's and Quality Assurance.
* Quality Agreements: Coordinating the issuance and approval of Quality Agreements with contract labs.
* GMP Audits: Participating in GMP audits to the contract labs.
* Quarterly Meetings: Coordinating and leading quarterly meetings between contract labs and QC management.
* Troubleshooting: Identifying and solving technical problems at contract laboratories with QC Management.
* Daily Quality Control Metrics Meeting: Oversees and leads the daily quality control metrics meeting.
This role may be suitable for individuals with:
* Regulated Environment Experience: Current or prior experience working in a regulated environment.
* Independence and Teamwork: A proven ability to work independently or as part of a team.
* Troubleshooting Skills: Strong trouble-shooting and problem-solving skills.
To be considered for this opportunity, applicants should have a BS/BA in Chemistry, Biology, or a related field with 5+ years of experience in Laboratory Management and analytical testing, and some previous supervisory/leadership experience. Relevant experience may substitute for educational requirements.