Quality Assurance Supervisor

Garonit Pharmaceutical • Fairfield, NJ

17h • $90,000 - $120,000 • Onsite

About The Position

Garonit Pharmaceutical is seeking an experienced, hands-on Quality Assurance Supervisor to support operations at its Fairfield and Flanders, New Jersey facilities. The role oversees daily Quality Assurance activities, supports the development and maintenance of the Quality Management System (QMS), ensures compliance with current Good Manufacturing Practices (cGMP), and drives continuous improvement across both sites.

The supervisor oversees QA operations and personnel, maintains quality systems and documentation, supports investigations and regulatory readiness, and collaborates with Quality Control, Manufacturing, Operations, and other departments to resolve quality issues. This is a full-time, onsite position requiring regular travel between the two facilities.

Requirements

• Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• At least 5 years of Quality Assurance experience within pharmaceutical manufacturing or an FDA-regulated environment.
• Strong knowledge of cGMP, FDA regulations, 21 CFR Parts 210/211, and applicable ICH guidelines.
• Hands-on experience with QMS, deviations, CAPA, change controls, audits, and GMP documentation.
• Experience supporting FDA inspections, regulatory audits, and inspection readiness activities.
• Strong leadership, organizational, communication, and problem-solving skills.
• Excellent attention to detail and ability to manage multiple priorities in a fast-paced manufacturing environment.

Nice To Haves

• Previous supervisory or team leadership experience.
• Experience with LIMS, TrackWise, or other electronic quality management systems.

Responsibilities

• Supervise, train, and mentor Quality Assurance personnel to ensure 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 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.
• Travel regularly between the Fairfield and Flanders facilities.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan with Company match
• Paid time off (PTO)
• Paid holidays
• Discretionary year-end bonus consideration, based on Company and individual performance; not guaranteed
• Other benefits in accordance with applicable Company plans and policies

What This Job Offers

• Job Type: Full-time
• Career Level: Manager