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 inspection readiness activities.
• Support preparation of Annual Product Quality Reviews (APQRs).
• Maintain accurate quality records and ensure documentation meets cGMP standards.
• Collaborate with Quality Control, Manufacturing, Operations, and other departments to identify and resolve quality-related issues.
• Support implementation and maintenance of electronic quality systems, including LIMS, TrackWise, and other eQMS platforms.
• Identify opportunities for process improvements and support quality initiatives across both facilities.
• Promote adherence to applicable cGMP requirements, regulatory standards, and Company policies.
• Perform other related duties as assigned based on business and quality needs.

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline preferred.
• 3–5 years of Quality Assurance experience within pharmaceutical manufacturing or an FDA-regulated environment.
• Strong understanding of cGMP requirements, FDA regulations, and GMP documentation practices.
• Hands-on experience with deviations, CAPA, change controls, and batch record review.
• Experience supporting Quality Management Systems (QMS), regulatory audits, and inspection readiness activities preferred.
• Experience with LIMS, TrackWise, or other electronic quality management systems preferred.