Quality Assurance Supervisor

Quality Assurance Supervisor

Location: Fairfield & Flanders, NJ

Garonit Pharmaceutical is seeking an experienced, hands-on Quality Assurance Supervisor to join our growing Quality team, supporting operations at both our Fairfield and Flanders, New Jersey facilities. This role will oversee daily Quality Assurance activities, support the development and maintenance of our Quality Management System (QMS), ensure compliance with current Good Manufacturing Practices (cGMP), and drive continuous improvement initiatives across both sites.

Key Responsibilities

• Supervise, train, and mentor Quality Assurance personnel, ensuring compliance with cGMP requirements and Company procedures.
• Oversee daily QA operations across both facilities, including review and approval of SOPs, batch records, deviations, investigations, and other GMP documentation.
• Maintain and continuously improve the Quality Management System (QMS) in accordance with applicable regulatory requirements.
• Manage and support deviations, investigations, Corrective and Preventive Actions (CAPAs), and change controls.
• Review and approve Certificates of Analysis (COAs) and Certificates of Compliance (COCs), as authorized.
• Support Annual Product Quality Reviews (APQRs) and monitor quality performance metrics.
• Conduct internal audits and support FDA inspections, customer audits, and regulatory inspection readiness activities.
• Support implementation and maintenance of electronic quality systems, including LIMS, TrackWise, and other eQMS platforms.
• Collaborate with Quality Control, Manufacturing, Operations, and other departments to investigate and resolve quality-related issues.
• Identify opportunities for process improvements and implement effective quality initiatives across both facilities.
• Promote a culture of quality, accountability, and continuous improvement throughout the organization.
• Perform other related duties as assigned based on business and quality needs.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, or a related scientific discipline required.
• Minimum of 5 years of Quality Assurance experience within pharmaceutical manufacturing or an FDA-regulated environment.
• Previous supervisory or team leadership experience preferred.
• Strong knowledge of cGMP, FDA regulations, 21 CFR Parts 210/211, and applicable ICH guidelines.
• Hands-on experience with Quality Management Systems (QMS), deviations, CAPA, change controls, audits, and GMP documentation.