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Job: Quality Assurance Officer - Operations, Exela Pharma Sciences, Lenoir, NC

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General Information

Job title:
Quality Assurance Officer - Operations
Job location:
Lenoir, NC  28645 United States
Requisition code:
1245 Blowing Rock Blvd
Date posted:
Competitive benefits and excellent pay rates
Job category:
Manufacturing and Production
Employment type:
Full time

Job Description

Position Summary
The Quality Assurance Officer provides direct support for all activities in Label Control, Packaging and Labeling, and inspection. This position supports the Quality Systems within the Quality Assurance Unit ensuring compliance with federal regulations for current Good Manufacturing Practice (cGMP) for labeled and unlabeled finished drug products in a pharmaceutical environment.

Job Responsibilities
• Verification of IV bag BOM’s
• Monitors Pharmaceutical Operations in daily inspection activities to ensure personnel are following procedures
• Performs QA inspection of finished drug product units and samples for release / stability testing
• Manages reject cage for rejected finished drug products
• Retrieves finished drug product samples requests and deliver them to requestor
• Administer/prepare inspector qualification tests
• Assists in writing/revising/reviewing SOPs for applicable areas
• Initiates Material Evaluation Reports (MER) for destruction of expired finished drug products
• Make defects for Automated Inspection defect kits
• Performs QA inspection of labeled finished product vials
• Provides QA oversight to Pharmaceutical Operations and performs Acceptance Quality Limit (AQL) inspection
• Reconciles/reviews executed batch production records for batch release
• Ensures outgoing shipments meet guidelines and provide QA approval
• Acknowledges serialization information is accurate and provides approval after Packaging activities
• Other duties as assigned

Education Requirements
Bachelor’s Degree preferred and a minimum of 1 year working experience in the pharmaceutical manufacturing industry. Other combination of related education and experience may be accepted in lieu of working experience in the pharmaceutical industry.

Job Requirements

Job Requirements
Must be able to read and write English, perform mathematical calculations, follow instructions, attention to detail, multi-task, lift 50 pounds repeatedly and twist while lifting, stand for extended periods of time, and handle multiple priorities without undue stress or errors.
(Job number: 4045365)
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