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Supervisor of Quality Assurance
2 months ago
The impact you will have:
You will be responsible for Pharmaceutical Manufacturing Quality Operational Support including managing and storing of cGMP documentation, records issuance, and provide support in QA oversight of manufacturing activities as needed.
You will manage manufacturing documentation program lifecycle from issuance of documents to archival. Provide oversight of inventory tracking system for archived cGMP documentation.
You will be the System Administration of Master Control.
You will work with manufacturing to provide QA oversight of operations and to solve in any quality concerns during the manufacturing of product.
You will write, review, and approve SOPs and Forms for manufacturing processes.
You will Conduct/assist investigation process for quality event; participating in triage events, identifying root cause and corrective and preventive action.
What we are looking for:
You will have a minimum of a High School Diploma, GED or equivalent; Bachelor’s degree in a scientific discipline, preferred.
You will have a minimum of three (5) years of experience with FDA and cGMP requirements in a pharmaceutical environment.
You will have a minimum of three (3) years of experience with Quality Assurance / Quality Control practices in a pharmaceutical environment.
You will have a basic understanding of manufacturing in cGMP environment, documentation and data integrity requirements.
You will have strong written and verbal communication and employee relation skills.
You will be proficient in Windows applications (Word, Excel, PowerPoint, Outlook, etc.) and other basic computer skills.
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