Summary: The Quality System Specialist participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Engineering, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. The Quality Systems Specialist provides oversight of the Quality Management System (QMS) implementation and use. This position may also support global elements of the QMS and lead or participate in continual improvement initiatives.
Essential Duties and Responsibilities: include, but are not limited to, the following:
Responsible for ensuring compliance with all aspects of quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
Maintains regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
Collaborates with cross functional teams to resolve issues, complete investigations and maintain compliance.
Responsible for QA review and approval of the following types of documents:
- Failure investigations
- Corrective and preventative actions (CAPA)
- Standard operating procedures (SOP’s)
- GxP documents
- Change control documents
Reviews various system records for assignment, compliance, and closure.
Provides administrative support of electronic systems
Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
Provision of monitoring and trending metrics associated with site quality systems.
Actively participate in continuous improvement ideas, initiation, and implementation.
Participation in internal, regulatory and customer audits.
May train personnel on quality system processes.
May supervise team members.
Perform additional duties as requested.
Education and Experience:
Principal Quality Systems Specialist: Requires BS/BA in scientific discipline or related field and 8 years of industry/relevant experience or equivalent combination of education and experience.
Senior Quality Systems Specialist: Requires BS/BA in scientific discipline or related field and 5 years of industry/relevant experience or equivalent combination of education and experience.
Knowledge, Skills, and Abilities:
Ability to develop relationships and coach business users on QMS system requirements.
Excellent written, oral and interpersonal communication skills with ability to effectively interact with a broad spectrum of audiences.
Excellent time management, communication, and organizational skills along with a proven ability to multi-task required.
Knowledge of quality and cGMP principles and systems and relevant regulatory guidelines.
Exhibits a drive for results, dealing with ambiguity, learning on the job and individual courage with a strong attention to detail.
Project management skills with the ability to manage many diverse tasks simultaneously.
Effectively organizes and manages work responsibilities under general guidance.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.