Temp Senior Qc Specialist Job In Munster

Job Description

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. Overseeing and leading the daily quality control metrics meeting.
13. Managing compliance items and metrics within the group.

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 a 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.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.