The Quality System Specialist plays a vital role in maintaining site compliance with regulatory requirements and company expectations. This specialist provides oversight of the Quality Management System (QMS) implementation and use, supporting global elements and leading continual improvement initiatives.
Key Responsibilities:
* Ensure compliance with all aspects of quality for the Raheen site, including manufacturing, quality systems, quality control, validation, facilities, and materials management.
* Maintain regulatory compliance according to current Good Manufacturing Practices (cGMP).
* Collaborate with cross-functional teams to resolve issues, complete investigations, and maintain compliance.
* Review and approve documents such as Failure Investigations, Corrective and Preventative Actions (CAPA), Standard Operating Procedures (SOP's), GxP documents, and Change Control documents.
* Monitor and report on trending metrics associated with site quality systems.
Requirements:
* Bachelor's degree in a scientific discipline.
* 8 years of experience in Pharma or Biotech for Principal Quality Systems Specialist, or 5 years for Senior Quality Systems Specialist.
* Equivalent combination of education and experience will be considered.
* Excellent written, oral, and interpersonal communication skills.
* Time management, communication, and organizational skills.
* Demonstrated project management skills and proficiency in Microsoft Office Suite.
Benefits:
Regeneron offers an inclusive and diverse culture, comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees.
Regeneron is an equal opportunity employer and welcomes applicants from diverse backgrounds.