Senior Quality Assurance Associate

• →Review and maintain GMP documentation, including SOPs, batch records, and quality records.
• →Support Quality Management System (QMS) activities, ensuring compliance with applicable regulatory requirements and Company procedures.
• →Assist with deviations, investigations, Corrective and Preventive Actions (CAPAs), and change control processes.
• →Review Certificates of Analysis (COAs), Certificates of Compliance (COCs), and related quality documentation.
• →Support batch record review and product disposition activities in accordance with established procedures.
• →Assist with internal audits, customer audits, FDA inspections, and regulatory inspection readiness activities.
• →Support preparation of Annual Product Quality Reviews (APQRs).
• →Maintain accurate quality records and ensure documentation meets cGMP standards.
• →Collaborate with Quality Control, Manufacturing, Operations, and other departments to identify and resolve quality-related issues.
• →Support implementation and maintenance of electronic quality systems, including LIMS, TrackWise, and other eQMS platforms.
• →Identify opportunities for process improvements and support quality initiatives across both facilities.
• →Promote adherence to applicable cGMP requirements, regulatory standards, and Company policies.
• →Perform other related duties as assigned based on business and quality needs.

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline preferred.
• 3–5 years of Quality Assurance experience within pharmaceutical manufacturing or an FDA-regulated environment.
• Strong understanding of cGMP requirements, FDA regulations, and GMP documentation practices.
• Hands-on experience with deviations, CAPA, change controls, and batch record review.
• Experience supporting Quality Management Systems (QMS), regulatory audits, and inspection readiness activities preferred.
• Experience with LIMS, TrackWise, or other electronic quality management systems preferred.
• Strong organizational, communication, and problem-solving skills.
• Excellent attention to detail and ability to manage multiple priorities in a fast-paced manufacturing environment.
• Ability to work independently and collaboratively with cross-functional teams.

This is a full-time, onsite position supporting both our Fairfield and Flanders, New Jersey facilities. The Senior Quality Assurance Associate will play an important role in maintaining compliant quality systems, supporting daily QA operations, ensuring accurate GMP documentation, and contributing to regulatory inspection readiness and 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.