Supervisor of Quality Assurance
Nebraska City, NE
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.