What are the responsibilities and job description for the Quality Assurance Associate position at garonitpharmaceutical?
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