Temp Senior QC Specialist

The successful candidate will manage and support the external testing activities within the Quality Control group in support of the company’s quality program.

A typical day might include, but is not limited to, the following:

1. Organizing and scheduling external testing to support product release/stability testing under cGMP
2. Managing external data review per production schedule and stability program
3. Performing the single point of contact role with contract laboratory facilities
4. Evaluating and monitoring the performance of the contract labs
5. Coordinating investigation activities at contract laboratories to ensure thorough technical content and compliant documentation
6. Communicating and soliciting input from Regeneron SME’s and Quality Assurance
7. Coordinating the issuance and approval of Quality Agreements with contract labs
8. Authoring Master service Agreements, as necessary
9. Participating in GMP audits to the contract labs
10. Coordinating and leading quarterly meetings between contract labs and QC management
11. Identifying and solving technical problems at contract laboratories with QC Management
12. Oversees and leads the daily quality control metrics meeting
13. Managing compliance items and metrics within the group

This role might be for you if:

1. You have current or prior experience working in a regulated environment
2. You have a proven ability to work independently or as part of a team
3. You possess strong trouble-shooting and problem solving skills

To be considered for this opportunity, you should have a 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. Will substitute relevant experience in lieu of educational requirement.

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