- 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
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Quality Compliance Specialist - Tarrytown, United States - Regeneron Pharmaceuticals, Inc
Description
As a Quality Compliance 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 :
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
