This role 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.
As a Quality Compliance Specialist a typical day might include, but is 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 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
May lead & support root cause analysis ensuring appropriate CAPA are implemented to prevent recurrence where relevant as a quality approver
Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements
Monitoring and trending metrics associated with site quality systems
Actively participate in continuous improvement ideas, initiation, and implementation
May participate in internal, regulatory and customer audits
May train personnel on quality system processes
Perform additional duties as requested
To be considered for this opportunity you should have a BS/BA in scientific discipline or related field with 2+ years of relevant work experience in pharmaceutical or related industry. Relevant experience may be substituted for education requirement. Experience with determining root cause and working knowledge of root cause analysis tools advantageous.
#IRELIM #JOBSIEPR #REGNIEQA #LI-Onsite
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.