Quality Assurance Specialist, On the Floor

Regeneron Pharmaceuticals, Inc. is seeking a Quality Assurance Specialist to provide on-the-floor QA support for product and raw-material disposition. The role ensures compliance with quality policies and cGMP requirements, supports investigations and process improvement, and provides guidance and training to employees and external partners.

Responsibilities

• Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communication
• Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization
• Provides consultation or advice in alignment with QA policies through a continuous on the floor presence, working with stakeholders by providing QA guidance to events or questions that may arise
• Perform activities associated with disposition of product (e.g., manufacturing record review, document review, source data review etc.)
• Review, edit, or approve Regeneron controlled documents
• Review and approve investigations associated with product or processes
• Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
• Supervising direct reports
• Participates with employee training to ensure that all requirements are met
• Performs, minimally, monthly performance feedback meetings with direct reports

Benefits

• Depending on country and role: annual bonuses or other incentive plans
• Depending on country and role: equity awards
• Depending on country and role: pension or retirement benefits
• Depending on country and role: 401(k) company match
• Depending on country and role: health and wellness programs
• Depending on country and role: fitness centers
• Depending on country and role: insurance benefits (e.g. medical, dental, vision, life and disability)
• Depending on country and role: paid time off
• Depending on country and role: family support benefits

Company

• Develops and commercializes biopharmaceutical medicines for serious diseases
• Tarrytown, New York, USA
• http://www.regeneron.com/
• Founded in 1988
• 10001+ employees

Qualifications

• BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience
• Senior QA Specialist: 6+ years of relevant experience
• QA Specialist: 2+ years of relevant experience
• Experience with drug substance
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

Required skills

• CAPA, Change Control, Deviation Investigation, Document Review, Drug Substance, Manufacturing Record Review, Quality Assurance, Source Data Review, cGMP

Experience

• 2+ years