GaronitPharmaceutical
Quality Assurance Associate
Fairfield, New Jersey
Sponsorship not specifiedDetected 23 days ago
ExcelAuditingGMPFDA RegulatoryCommunicationMicrosoft Office
About the role
- 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.
Responsibilities
- Issue, review, and maintain batch records
- Track material status and maintain data integrity
- Author, revise, and manage SOPs and controlled documents
- Write investigations, change controls, and implement CAPAs
- Support internal, customer, and regulatory audits
- Perform data entry, collection, and documentation review
- 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.
Requirements
- Minimum 1-3 years of experience in a regulated cGMP pharmaceutical manufacturing environment
- 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
- 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
- FDA-regulated industry experience
- Excellent documentation accuracy and attention to detail
- Strong organizational, written, and verbal communication skills
Nice to have
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline preferred
- Experience supporting QC systems and auditing laboratory documentation/data is strongly preferred
- Experience with Empower software is preferred
Compensation
- Compile data for Annual Product Reviews (APRs)
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