Quality Assurance Supervisor

Garonit Pharmaceutical; Fairfield (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

Garonit Pharmaceutical in Fairfield and Flanders, New Jersey, seeks an experienced Quality Assurance Supervisor to lead daily QA activities, ensure cGMP compliance, and drive continuous improvement across both facilities.

You will supervise QA staff, maintain the QMS, review deviations and CAPAs, support FDA inspections, and collaborate with Manufacturing and Quality Control to resolve quality issues while promoting a culture of excellence.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum of 5 years of QA experience in pharmaceutical manufacturing or an FDA-regulated setting.
• Previous supervisory or team leadership experience preferred.
• Hands-on experience with QMS, deviations, CAPA, change controls, audits, and GMP documentation.

Responsibilities

• Supervise QA personnel and ensure compliance with cGMP and company procedures.
• Oversee daily QA operations across two NJ facilities, including review of SOPs, batch records, deviations and investigations.
• Maintain and improve the QMS per regulatory requirements.
• Support FDA inspections, regulatory audits, and inspection readiness activities.
• Collaborate across Quality Control, Manufacturing and Operations to resolve quality issues.

Skills

Leadership

Organization

Communication

Problem-solving

Education

Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, or related

Tools

LIMS

TrackWise

eQMS

Job description

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.
• Experience supporting FDA inspections, regulatory audits, and inspection readiness activities.
• Experience with LIMS, TrackWise, or other electronic quality management systems preferred.
• Strong leadership, organizational, communication, and problem‑solving skills.
• Excellent attention to detail and ability to manage multiple priorities in a fast‑paced manufacturing environment.

The anticipated salary range for this position is $90,000–$120,000 per year. Actual compensation will be determined based on factors such as experience, qualifications, skills, and other job‑related considerations.This position is also eligible for consideration for a discretionary year‑end bonus, based on Company and individual performance. Any bonus is discretionary and is not guaranteed.

Garonit Pharmaceutical offers eligible employees a benefits package that includes medical, dental, and vision insurance; a 401(k) retirement plan with Company match; paid time off (PTO); paid holidays; and other benefits in accordance with applicable Company plans and policies.

About The Role

This is a full‑time, onsite position supporting both our Fairfield and Flanders, New Jersey facilities. The Quality Assurance Supervisor will play a key role in overseeing daily QA operations, maintaining compliant quality systems, supporting regulatory inspection readiness, and driving continuous improvement across our pharmaceutical manufacturing operations. Regular travel between both facilities will be required.

Garonit Pharmaceutical is an equal opportunity employer. We consider qualified applicants for employment without regard to race, color, religion, sex, pregnancy, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.