Logo
Garonit Pharmaceutical

Quality Assurance Associate

Garonit Pharmaceutical, Fairfield, New Jersey, us, 07004

Save Job

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.

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

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 reviewReview shipment inspection forms

Assist with other QA duties as assigned

What You Bring

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

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

Seniority level Entry level

Employment type Full-time

Job function Quality Assurance

Industries Pharmaceutical Manufacturing

#J-18808-Ljbffr