Quality Assurance Supervisor

Garonit Pharmaceutical•Mount Olive, NJ

4d•Onsite

About The Position

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.

Requirements

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.

Responsibilities

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.