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Quality System Specialist Jobs
Company | Germer International - Pharmaceutical Recruiting |
Address | Lincoln, Nebraska Metropolitan Area, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research,Pharmaceutical Manufacturing |
Expires | 2023-08-23 |
Posted at | 9 months ago |
Our client, a unique pharmaceutical company in Nebraska, is looking to add a Quality Systems Specialist to their growing team. As a Quality Systems Specialist, you will be responsible for leading and overseeing the company’s quality systems operations.
Responsibilities:
- Write, review, and approve SOPs and Forms for manufacturing processes.
- System Administration of Master Control.
- Manage documentation program lifecycle from issuance of documents to archival. Provide oversight of inventory tracking system for archived cGMP documentation.
- Conduct/assist investigation process for quality event; participating in triage events, identifying root cause and corrective and preventive action.
- Work with manufacturing to provide QA oversight of operations and to solve any quality concerns during the manufacturing of product.
- Responsible for Quality Operational Support including managing and storing of cGMP documentation, records issuance, and provide support in QA oversight of manufacturing activities as needed.
Requirements:
- Minimum of a High School Diploma, GED or equivalent; Bachelor’s degree in a scientific discipline, preferred.
- Minimum of three (3) years of experience with Quality Assurance / Quality Control practices in a pharmaceutical environment.
- Minimum of three (3) years of experience with FDA and cGMP requirements in a pharmaceutical environment.
- Basic understanding of manufacturing in cGMP environment, documentation and data integrity requirements.
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