Quality Assurance Associate

Garonit Pharmaceutical; Fairfield (NJ); On-site; USD 65,000 - 85,000; Full time

Job summary

Garonit Pharmaceutical is looking for a detail-oriented QA Associate in Flanders, NJ and Fairfield, NJ. This role supports daily Quality Assurance operations, ensuring product quality and cGMP compliance. Responsibilities include issuing and reviewing batch records, preparing documentation, and supporting audits.

The ideal candidate will have a Bachelor’s degree in a scientific discipline and 1-3 years of experience in a regulated pharmaceutical environment. Strong attention to detail, organizational skills, and proficiency in software like Empower are essential.

Qualifications

• Minimum 1-3 years of experience in a regulated cGMP pharmaceutical manufacturing environment.
• FDA-regulated industry experience is preferred.
• Strong understanding of cGMP and Quality Management Systems.

Responsibilities

• Issue, review, and maintain batch records.
• Prepare and review documentation for Operations.
• Conduct employee training.

Skills

Attention to detail

Organizational skills

Verbal communication

Written communication

Proficiency in Microsoft Word and Excel

Education

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

Tools

Empower software

Job description

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
• 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:

• 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