Quality Compliance Specialist (Distribution Compliance)

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Job description

We are currently looking to hire a Quality Compliance Specialist, who supports assurance of timely commercial and clinical product supply through comprehensive review of product documentation and provision of documentation required for product release.

The day to day of this position can include, but are not limited to:

• Ensure compliance with global requirements in support of lot release for clinical and commercial product distribution.
• Perform comprehensive review of supporting product documentation and identify discrepancies.
• Determine source of any differences or issues found upon review of the documentation.
• Raise discrepant findings to team management in product documentation for cross-functional regulatory and quality assessment.
• Assess discrepancies for product impact and author justifications, where possible.
• Support and/or lead meetings relevant to discrepant findings.
• Guide cross-functional activities to meet objectives as a liaison between QA and other functions, where possible.
• Proactively engage in activities in order to meet schedules and resolve problems.
• Identify and implement continuous improvement initiatives.
• Support QA project initiatives for a broad range of topics as the QA Distribution Compliance group evolves.
• Perform other support responsibilities as requested.

Education and Experience:

• Associate Specialist: requires a minimum BA/BS degree or MS degree preferably in a science subject area with 0-2 years of industry/relevant experience.
• Specialist: requires a minimum BA/BS degree preferably in a science subject area with +2 of industry/relevant experience or a MS degree with 1+ year of industry/relevant experience.
• Senior Specialist: Requires a minimum BA/BS degree preferably in a science subject area with 5+ years of industry/relevant experience, or MS degree with 4+ years of industry/relevant experience, or a PhD with 0-2 years of industry/relevant experience

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.