Job Description
This role involves ensuring site compliance with all aspects of quality, inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
1. Administering and overseeing site quality systems, including deviations, CAPA, change control, audits, customer complaints, quality risk management, and reviewing documents related to area functions.
2. Maintaining electronic systems used for Change Control and Deviation Management.
3. Reviewing procedures, policies, and instructional documents relating to quality systems to ensure compliance with company policy and local/international regulatory requirements.
4. Monitoring and trending metrics associated with site quality systems.
5. Participating in continuous improvement initiatives, regulatory/customer audits, quality risk assessments, and collaborating with functional departments to resolve issues and maintain compliance.
Required Skills and Qualifications
To be considered for this position, you must have:
* A proven track record of conducting on-site investigations and analysis (GEMBA walks).
* The ability to identify and address operational inefficiencies.
* Experience implementing process improvements based on findings from direct workplace engagement.
* Demonstrated respectful behavior at all times.
* Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint).
Candidates must hold a Specialist: BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of relevant work experience in pharmaceutical or related industry. Senior Specialists require 5+ years of relevant experience.
Benefits
We offer an inclusive and diverse culture that provides comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Others
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, nationality, national origin, age, disability, or any other protected characteristic.