Senior QA On-the-Floor Supervisor – 3rd Shift

Regulatory Jobs; City of Rensselaer (NY); Sur place; USD 79 000 - 129 000; Plein temps

Résumé du poste

Regeneron is seeking a Supervisor Quality Assurance Specialist to lead on-the-floor QA activities supporting disposition of product and raw materials. You will ensure compliance with QA policies, cGMPs, SOPs, and Regeneron standards, while mentoring staff and addressing complex investigations.

You will represent QA with external partners, provide guidance on regulatory communications, and drive continuous process improvements within a 3rd shift on-site role in Rensselaer, NY.

Qualifications

• BS/BA in Life Sciences, Engineering or related field with six years of relevant experience or equivalent combination of education and experience.
• Experience with drug substance manufacturing.

Responsabilités

• Represent Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution.
• Liaise with external partners and provide input on regulatory communication.
• Train and mentor employees, providing QA guidance on processes and procedures.
• Perform disposition activities for product and/or raw materials (e.g., manufacturing record review, document review, source data review).
• Review, edit, or approve Regeneron controlled documents; review investigations associated with product or processes.
• Participate in continuous improvement of Regeneron processes and supervise direct reports; conduct monthly performance feedback with direct reports.

Connaissances

Quality Assurance

Deviations handling

Change controls

CAPAs

Formation

BS/BA in Life Sciences, Engineering or related field

Six years of relevant experience

Description du poste

Regeneron is seeking a Supervisor Quality Assurance Specialist to lead on-the-floor QA activities supporting disposition of product and raw materials. You will ensure compliance with QA policies, cGMPs, SOPs, and Regeneron standards, while mentoring staff and addressing complex investigations.

You will represent QA with external partners, provide guidance on regulatory communications, and drive continuous process improvements within a 3rd shift on-site role in Rensselaer, NY.