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Quality Compliance Specialist (Deviations)

Job Description

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As a Quality System Specialist you will participate 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. Please note this is an onsite position.

A typical day might include, but is not limited to the following:

  • Ensuring compliance with all aspects of quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management

  • Maintaining regulatory compliance in accordance with current Good Manufacturing Practices (cGMP)

  • Collaborating 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 investigation / Corrective and preventative actions (CAPA) / Standard operating procedures (SOP’s) / GxP documents / Change control documents

  • Reviewing various system records for assignment, compliance and closure

  • Providing administrative support of electronic systems

  • Reviewing 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 participating in continuous improvement ideas, initiation, and implementation

  • Participating in internal, regulatory and customer audits

  • May train personnel on quality system processes

  • May supervise team members

  • Performing additional duties as requested

To be considered for the Quality Systems Specialist position you should have a BS/BA in a scientific discipline or related field and 2 years of industry/relevant experience or equivalent combination of education and experience. For the Senior Quality Systems Specialist position you should have a BS/BA in a scientific discipline or related field and 5 years of industry/relevant experience or equivalent combination of education and experience.

#LI-Onsite #REGNIEQA #JOBSIEPR #IRELIM

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.