Quality Systems Specialist

Job Description

As a Quality Systems Specialist, you will be responsible for leading and overseeing the company’s quality systems operations.

Responsibilities:

• You will be 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.
• You will manage 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 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.

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 FDA and cGMP requirements in a pharmaceutical environment.
• Minimum of three (3) years of experience with Quality Assurance / Quality Control practices in a pharmaceutical environment.
• Basic understanding of manufacturing in cGMP environment, documentation and data integrity requirements.
• Strong written and verbal communication and employee relation skills.
• Proficient in Windows applications (Word, Excel, PowerPoint, Outlook, etc.) and other basic computer skills.