Quality Assurance Associate

QA Associate

Onsite in Flanders, NJ and 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.

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 review

Review shipment inspection forms

Assist with other QA duties as assigned

What You Bring:

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline preferred

Minimum 1-3 years of experience in a regulated cGMP pharmaceutical manufacturing environment

FDA-regulated industry experience

Experience supporting QC systems and auditing laboratory documentation/data is strongly preferred

Experience with Empower software is preferred

Working knowledge of 21 CFR Parts 210/211 and ICH guidelines

Strong understanding of cGMP and Quality Management Systems

Experience reviewing laboratory documentation, analytical data, and quality records

Excellent documentation accuracy and attention to detail

Strong organizational, written, and verbal communication skills

Proficiency in Microsoft Word and Excel

Ability to multitask in a fast-paced environment

Strong interpersonal skills with the ability to work independently and collaboratively across departments