What are the responsibilities and job description for the Quality Systems Specialist position at W3Global Inc.?
Job Description
Job Description
Quality Systems Specialist
This position will be located at Omaha, NE, working with different management levels and support personnel in other office locations.
The impact you will have :
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.
Manage documentation program lifecycle from issuance of documents to archival. Provide oversight of inventory tracking system for archived cGMP documentation.
System Administration of Master Control.
Prepare and review documentation for release of finished product. Provide support in final release of finished product.
Partner with manufacturing to provide QA oversight of operations and to solve in any quality concerns during the manufacturing of product.
Write, review, and approve SOPs and Forms for manufacturing processes.
Report quality issues to management.
Educate manufacturing team on quality control issues and work with departmental managers to improve overall company product quality.
Conduct / assist investigation process for quality event; participating in triage events, identifying root cause and corrective and preventive action.
As the workload demand changes for the department, additional responsibilities may be required.
What we are looking for :
Minimum high school diploma, GED or equivalent required
Bachelor's degree in a science discipline preferred
Minimum of 3 years of experience with US FDA and cGMP requirements
Minimum of 3 years of experience with Quality Assurance and / or Quality Control practices
Basic understanding of manufacturing in cGMP environment, documentation and data integrity requirements
Experience managing systems, including problem-solving skills
Strong attention to detail, time management, and organizational skills
Advanced computer skills, including Outlook, Excel, Word, PowerPoint and quality systems (MasterControl)
Strong verbal and written communication skills, including the ability to organize information and present it to peers and members of Senior Management
