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
Skills Required
- Minimum 1-3 years experience in a regulated cGMP pharmaceutical manufacturing environment
- FDA-regulated industry experience
- 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 and ability to work independently and collaboratively
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related scientific discipline
- Experience supporting QC systems and auditing laboratory documentation/data
- Experience with Empower software
What We Do
Garonit Pharmaceutical, a US-based multinational company owned by brothers Rohit and Nitin Garg, is making a global impact with its high-quality Active Pharmaceutical Ingredients (APIs). Headquartered in New Jersey, Garonit has expanded its reach to markets in the UK, Switzerland, Hong Kong, Brazil, and China. The company’s proactive and collaborative approach, along with a willingness to take risks, has earned it accreditations from top regulatory bodies like the FDA, EDQM, PMDA, and EPA. Garonit is known for its strong compliance standards, partnering with notable organizations such as Ernst & Young, SAP, and Citibank. This commitment to compliance has helped Garonit serve Fortune 500 companies and small-scale industries across North America, LATAM, and EMEA. Our state-of-the-art manufacturing plants in New Jersey, USA, and India are cGMP and US-FDA compliant. Additionally, we operate warehouses in Germany and the UK, ensuring efficient distribution worldwide. Beyond business, Garonit is dedicated to philanthropy. We partner with UNICEF, WHO, and The Red Cross to improve global health and welfare. Through our own Neelam Garg Foundation, we actively support girls’ education in underprivileged communities, aiming to make a positive impact on society.
Why Work With Us
Garonit Pharmaceutical, a US-based multinational owned by Rohit and Nitin Garg, excels in Active Pharmaceutical Ingredients (APIs). With headquarters in New Jersey and plants in the USA and India, it serves global markets like the UK, Switzerland, Hong Kong, Brazil, and China. Accredited by FDA, EDQM, PMDA, and EPA.
