Quality Assurance Supervisor

Garonit Pharmaceutical; Flanders (NJ); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation

Long-term career growth

Collaborative culture

Job summary

Garonit Pharmaceutical seeks a hands-on Quality Assurance Supervisor to build and sustain a modern QMS in a fast-growing startup-like environment. You will drive GMP-compliant processes, lead audits, and mentor QA staff while partnering with cross-functional teams to ensure product quality from development through manufacturing.

You will oversee data-driven CAPA, document control, and continuous improvement initiatives, shaping a digital-first quality culture and supporting upcoming product

Qualifications

• Bachelor's degree required in a related field and 3–5 years of pharma QA experience.
• Proven experience establishing or managing Quality Systems and audit readiness.
• Strong GMP, QMS, ISO 9001 understanding and hands-on tool experience.

Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS).
• Drive transition from paper to electronic systems (LIMS, TrackWise).
• Conduct internal audits and ensure inspection readiness (PAI, regulatory).
• Review and approve SOPs, batch records, deviations, and change controls.

Skills

Leadership

GMP knowledge

LIMS/TrackWise experience

QA audits

Data analysis

Education

Bachelor's degree

Tools

LIMS

TrackWise

eQMS

Job description

Quality Assurance Supervisor

Onsite in Flanders, NJ

We’re looking for a Quality Assurance Supervisor who’s hands‑on, meticulous, and passionate about setting up quality systems. You’ll play a key role in developing and implementing our Quality Management System (QMS), preparing for pre‑approval inspections, and supporting new product development.

What You’ll Do

• Develop, implement, and maintain the Quality Management System (QMS).
• Drive the transition from paper‑based to electronic systems (LIMS, TrackWise).
• Conduct internal audits and ensure inspection readiness (PAI, regulatory).
• Ensure compliance with cGMP and industry standards.
• Review and approve SOPs, batch records, deviations, and change controls.
• Analyze quality data to identify trends and drive continuous improvement.
• Develop and implement Corrective and Preventive Actions (CAPA).
• Coordinate with other departments to resolve quality issues quickly and effectively.
• Prepare and present quality performance reports to management.
• Train and mentor QA staff to build a culture of quality and excellence.

What You’ll Bring

• Bachelor’s degree in related field
• 3–5 years of experience in pharma QA supporting drug product development and manufacturing.
• Proven experience in establishing or managing Quality Systems and preparing for audits/inspections.
• Strong understanding of GMP, QMS, and ISO 9001 standards.
• Hands‑on experience with LIMS, TrackWise, or other eQMS tools.
• Excellent leadership, communication, and problem‑solving skills.
• Highly meticulous, data‑driven, and comfortable in a fast‑paced, startup-like environment.

Why Garonit Pharma

• Be part of a core leadership team with exciting growth plans for the future.
• Shape a modern, digital‑first Quality Management System.
• Collaborate with experienced professionals passionate about quality and innovation.
• Competitive compensation and long‑term career growth opportunities.