Garonit Pharma
Quality Assurance Associate Fairfield, New Jersey
Garonit Pharma, Fairfield, New Jersey, us, 07004
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.
What You’ll Be Doing:
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
Schedule calibration and certification activities
Respond to customer requests and questionnaires
Perform data entry, collection, and documentation review
Assist with other QA duties as assigned
What You Bring:
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
Why Join Garonit Pharma? You'll be part of a growing, collaborative team committed to quality, innovation, and continuous improvement in pharmaceutical manufacturing.
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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.
What You’ll Be Doing:
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
Schedule calibration and certification activities
Respond to customer requests and questionnaires
Perform data entry, collection, and documentation review
Assist with other QA duties as assigned
What You Bring:
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
Why Join Garonit Pharma? You'll be part of a growing, collaborative team committed to quality, innovation, and continuous improvement in pharmaceutical manufacturing.
#J-18808-Ljbffr