Quality Assurance Associate

Quality Assurance Associate role at Garonit Pharmaceutical

Onsite in Fairfield, NJ

Garonit Pharma is seeking a detail-oriented and collaborative QA Associate to support daily Quality Assurance operations and uphold our Quality Management System. This role is essential in ensuring product quality, cGMP compliance, and smooth operational support across manufacturing and warehouse functions. If you’re passionate about quality, documentation excellence, and continuous improvement, we want to meet you.

• Issue, review, and maintain batch records
• Prepare and review documentation for Operations
• Review Certificates of Analysis (COAs)
• Track material status and maintain data integrity
• Author, revise, and manage SOPs and controlled documents
• Write investigations, change controls, and implement CAPAs
• Conduct employee training
• Support internal, customer, and regulatory audits
• Compile data for Annual Product Reviews (APRs)
• Schedule calibration and certification activities
• Respond to customer requests and questionnaires
• Track vendor qualifications
• Perform data entry, collection, and documentation review
  
  Review shipment inspection forms
• Assist with other QA duties as assigned

• Bachelor’s degree (science major preferred)
• Minimum 1 year of experience in a regulated cGMP environment (pharmaceutical manufacturing preferred)
• FDA-regulated industry experience
• Working knowledge of CFR & ICH guidelines
• Strong understanding of cGMP processes
• Excellent documentation accuracy and attention to detail
• Strong organizational, written, and verbal communication skills
• Proficiency in Microsoft Word & Excel
• Ability to multitask in a fast-paced environment
• Strong interpersonal skills and ability to work with minimal supervision

You’ll be part of a growing, collaborative team committed to quality, innovation, and continuous improvement in pharmaceutical manufacturing.

Entry level

Full-time

Quality Assurance

Pharmaceutical Manufacturing