Quality System Specialist
Maintain site compliance of operations in accordance with mandated regulatory requirements and site expectations.
Key Responsibilities:
* Evaluate and ensure compliance with all aspects of quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
* Maintain regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
* Collaborate with cross-functional teams in resolving issues, completing investigations, and maintaining compliance.
* Review various system records for assignment, compliance, and closure.
* Provide administrative support of electronic systems.
Requirements:
* Bachelor's degree in a scientific discipline.
* Minimum 5-8 years experience within Pharma or Biotech industry.
* Equivalent combination of education and experience will be considered.
About Regeneron
We have an inclusive and diverse culture that provides comprehensive benefits. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, nationality, national or ethnic origin, civil status, age, citizenship status, 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.