Senior Quality Assurance Associate

Senior Quality Assurance Associate

Location: Fairfield & Flanders, NJ

Garonit Pharmaceutical is seeking a detail-oriented Senior Quality Assurance Associate to join our growing Quality team, supporting operations at both our Fairfield and Flanders, New Jersey facilities. This role will support daily Quality Assurance activities, maintain compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and internal quality standards, and assist with quality systems, investigations, audits, and continuous improvement initiatives.

Key Responsibilities

• Review and maintain GMP documentation, including SOPs, batch records, and quality records.
• Support Quality Management System (QMS) activities, ensuring compliance with applicable regulatory requirements and Company procedures.
• Assist with deviations, investigations, Corrective and Preventive Actions (CAPAs), and change control processes.
• Review Certificates of Analysis (COAs), Certificates of Compliance (COCs), and related quality documentation.
• Support batch record review and product disposition activities in accordance with established procedures.
• Assist with internal audits, customer audits, FDA inspections, and regulatory i