Senior Quality Assurance Associate
About The Position
Garonit Pharmaceutical is seeking a detail-oriented Senior Quality Assurance Associate to support daily Quality Assurance activities at its Fairfield and Flanders, New Jersey facilities. The role supports compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and internal quality standards, and contributes to quality systems, investigations, audits, and continuous improvement initiatives. This full-time, onsite position supports both facilities and requires regular travel between them. The associate will help maintain compliant quality systems, support daily QA operations, ensure accurate GMP documentation, and contribute to regulatory inspection readiness and continuous improvement across pharmaceutical manufacturing operations.
Requirements
- 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.
- 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.
- Regular travel between the Fairfield and Flanders facilities is required.
Nice To Haves
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline preferred.
- Experience supporting Quality Management Systems (QMS), regulatory audits, and inspection readiness activities preferred.
- Experience with LIMS, TrackWise, or other electronic quality management systems preferred.
Responsibilities
- Review and maintain GMP documentation, including SOPs, batch records, and quality records.
- Support Quality Management System (QMS) activities in 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 according to 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.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement plan with Company match
- Paid time off (PTO)
- Paid holidays
- Other benefits in accordance with applicable Company plans and policies
- Eligible for consideration for a discretionary year-end bonus based on Company and individual performance; bonus is not guaranteed
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What This Job Offers
Job Type
Full-time
Career Level
Senior
