Quality Assurance AssociateGaronit Pharmaceutical • Fairfield, California, United States
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Quality Assurance Associate
Garonit Pharmaceutical
- Fairfield, California, United States
- Fairfield, California, United States
À propos
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
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Compétences linguistiques
- English
Avis aux utilisateurs
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