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.
Skills Required
- Bachelor's degree in related field
- 3-5 years experience in pharmaceutical QA supporting drug product development and manufacturing
- Proven experience establishing or managing Quality Systems and preparing for audits/inspections
- Strong understanding of cGMP, QMS, and ISO 9001 standards
- Hands-on experience with LIMS, TrackWise, or other electronic QMS (eQMS) tools
- Experience conducting internal audits and ensuring inspection readiness (PAI, regulatory)
- Experience reviewing and approving SOPs, batch records, deviations, and change controls
- Experience analyzing quality data, driving continuous improvement, and implementing CAPA
- Strong leadership, communication, and problem-solving skills, with ability to train and mentor QA staff
- Comfortable working in a fast-paced, startup-like environment; highly meticulous and data-driven
What We Do
Garonit Pharmaceutical, a US-based multinational company owned by brothers Rohit and Nitin Garg, is making a global impact with its high-quality Active Pharmaceutical Ingredients (APIs). Headquartered in New Jersey, Garonit has expanded its reach to markets in the UK, Switzerland, Hong Kong, Brazil, and China. The company’s proactive and collaborative approach, along with a willingness to take risks, has earned it accreditations from top regulatory bodies like the FDA, EDQM, PMDA, and EPA. Garonit is known for its strong compliance standards, partnering with notable organizations such as Ernst & Young, SAP, and Citibank. This commitment to compliance has helped Garonit serve Fortune 500 companies and small-scale industries across North America, LATAM, and EMEA. Our state-of-the-art manufacturing plants in New Jersey, USA, and India are cGMP and US-FDA compliant. Additionally, we operate warehouses in Germany and the UK, ensuring efficient distribution worldwide. Beyond business, Garonit is dedicated to philanthropy. We partner with UNICEF, WHO, and The Red Cross to improve global health and welfare. Through our own Neelam Garg Foundation, we actively support girls’ education in underprivileged communities, aiming to make a positive impact on society.
Why Work With Us
Garonit Pharmaceutical, a US-based multinational owned by Rohit and Nitin Garg, excels in Active Pharmaceutical Ingredients (APIs). With headquarters in New Jersey and plants in the USA and India, it serves global markets like the UK, Switzerland, Hong Kong, Brazil, and China. Accredited by FDA, EDQM, PMDA, and EPA.
