Senior QA Associate — Onsite GMP & FDA Compliance (NJ)

Garonit Pharmaceutical; Fairfield (NJ); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid time off

Holiday pay

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

QA experience

cGMP knowledge

FDA regulations understanding

Documentation & record-keeping

Analytical problem-solving

Cross-functional collaboration

Education

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

Tools

LIMS

TrackWise

eQMS (general)

Job description

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