Senior Quality Assurance Associate

Garonit Pharmaceutical; Fairfield (NJ); Presencial; USD 60.000 - 80.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, and vision insurance

401(k) with company match

Paid time off

Holiday pay

Descripción de la vacante

Garonit Pharmaceutical is seeking a detail-oriented Senior Quality Assurance Associate to join our growing Quality team at our Fairfield and Flanders, New Jersey facilities. This on-site role supports daily QA operations, ensures compliance with cGMP and FDA regulations, and contributes to quality systems, investigations, audits, and continuous improvement initiatives.

The successful candidate will review GMP documentation, support CAPA and change controls, assist with internal and regulatory

Formación

• Bachelor's degree in a scientific field preferred.
• 3–5 years of QA experience in pharma or FDA-regulated environment.
• Strong understanding of cGMP and GMP documentation practices.
• Hands-on with deviations, CAPA, change controls, and batch review.
• Experience with QMS, regulatory audits and inspection readiness preferred.
• Experience with LIMS, TrackWise or other eQMS platforms preferred.
• Strong organization, communication and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced setting.
• Ability to work independently and with cross-functional teams.

Responsabilidades

• Review and maintain GMP documentation including SOPs and batch records.
• Support QMS activities ensuring regulatory compliance.
• Assist deviations, CAPA, change controls and root-cause analysis.
• Review COAs, COCs and related quality documentation.
• Support batch record review and product disposition activities.
• Assist internal and regulatory audits and inspection readiness.
• Support preparation of APQRs and quality reporting.
• Maintain accurate quality records and ensure cGMP standards.
• Collaborate with Quality Control, Manufacturing and other departments.
• Support eQMS implementation and maintenance (LIMS TrackWise, etc.).
• Identify opportunities for process improvements and quality initiatives.
• Promote adherence to cGMP and company policies.
• Perform other duties as assigned.

Conocimientos

QA experience

cGMP knowledge

FDA regulations understanding

Documentation & record-keeping

Analytical problem-solving

Cross-functional collaboration

Educación

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field

Herramientas

LIMS

TrackWise

eQMS (general)

Descripción del empleo

Garonit Pharmaceutical is seeking a detail-oriented Senior Quality Assurance Associate to join our growing Quality team, supporting operations at both our Fairfield and Flanders, New Jersey facilities. This role will support daily Quality Assurance activities, maintain compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and internal quality standards, and assist with quality systems, investigations, audits, and continuous improvement initiatives.

Key Responsibilities

• 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.

Qualifications

• 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.

The anticipated salary range for this position is $60,000–$80,000 per year. Actual compensation will be determined based on factors such as experience, qualifications, skills, and other job‑related considerations. This position is also eligible for consideration for a discretionary year‑end bonus, based on Company and individual performance. Any bonus is discretionary and is not guaranteed.

Garonit Pharmaceutical offers eligible employees a benefits package that includes medical, dental, and vision insurance; a 401(k) retirement plan with Company match; paid time off (PTO); paid holidays; and other benefits in accordance with applicable Company plans and policies.

About The Role

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.