Quality Assurance Specialist (Batch Record & Disposition)

About the role

Join our Quality Assurance (QA) team supporting the batch record & disposition team at Regeneron. This role involves performing and leading activities in support of dispositioning product while ensuring compliance with QA policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

Responsibilities

• Represent QA in support of complex and/or significant deviations, change controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Represent the IOPS (Industrial Operations Product Supply) organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on issues occurring at external sites
• Perform activities associated with disposition of product (e.g. document review, disposition pack preparation, Certificate of Analysis Review)
• Review, edit, or approve Regeneron controlled documents
• Review and approve investigations associated with raw materials, product, laboratory, facilities, or materials
• Continually evaluate Regeneron processes and procedures with an eye toward continuous improvement
• May train and/or mentor junior employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization

Requirements

• Bachelor's degree in life sciences or related field; may substitute proven experience for education requirement
• Associate QA Specialist: 2+ years of experience
• QA Specialist: 4 + years of experience

Qualifications

• Strong understanding of cGMPs and regulatory requirements
• Experience with quality assurance and compliance processes
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Proficiency in Microsoft Office Suite

Skills

• Quality Assurance
• Regulatory Compliance
• Document Control
• Investigation and Problem Resolution
• Process Improvement

Benefits

At Regeneron, we offer a competitive and comprehensive total rewards package which may include:

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (e.g. medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

For additional information about Regeneron benefits in the U.S., please visit here.

Pay

$62,355.00 - $110,000.00 annually

Schedule

Monday-Friday, 8am-4:30pm