Pharma QA Specialist - Deviations & CAPA Lead

BioSpace; City of Rensselaer (NY); On-site; USD 67,000 - 129,000; Full time

Job summary

Regeneron, located in Rensselaer, NY, seeks a Quality Assurance Specialist to lead floor activities for dispositioning product and raw materials, ensuring compliance with QA policies, cGMPs, and Regeneron standards.

The role involves handling deviations, change controls, CAPAs, and investigations, mentoring staff, reviewing documents, and collaborating with external partners to uphold regulatory readiness and continuous improvement. On-site shifts available.

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.
• Level will be determined based on experience.

Responsibilities

• Represent Quality Assurance in support of Deviations, Change Controls, CAPAs, including investigation, evaluation and problem resolution.
• Represents 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 insights on processes and procedures and QA expectations.
• Provide QA guidance on events or questions on the floor, working with stakeholders.
• Perform activities associated with disposition of product (e.g., MR review, document review, source data review).
• Review, edit, or approve Regeneron controlled documents.
• Review and approve investigations associated with product or processes.
• Continuously evaluating Regeneron processes and procedures for improvement.
• Supervise direct reports and participate in monthly performance feedback meetings.

Education

BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience

Job description

Regeneron, located in Rensselaer, NY, seeks a Quality Assurance Specialist to lead floor activities for dispositioning product and raw materials, ensuring compliance with QA policies, cGMPs, and Regeneron standards.

The role involves handling deviations, change controls, CAPAs, and investigations, mentoring staff, reviewing documents, and collaborating with external partners to uphold regulatory readiness and continuous improvement. On-site shifts available.