MQA Specialist
$60,966–$85,694 year
On-siteWilson, North Carolina, United States
Job Summary
Oversee production and support processes by verifying weighing and dispensing, monitoring in-process controls, and executing aseptic gowning qualifications. Conduct visual inspections (AQL), oversee filling and lyophilization activities, and manage finished product reserve sampling and FDA retention storage. Drive continuous quality improvement through shop-floor presence, 5S activities, and root-cause analysis for isolated or systemic issues. Escalate critical deviations to site management with immediate containment and CAPA proposals while ensuring adherence to SOPs and cGMPs. Review MBRs and logbooks for compliance and support validation/investigation studies. Participate in quality improvement projects and perform special oversight activities as assigned.
Required Qualifications
- Quality Assurance personnel
- Act with competency, integrity and appropriately
- Authorized to stop production activities
- Contain materials and/or products with immediate effect
- Escalate Isolated and Systemic issue to site management
- Propose CAPAs
- MQA shop-floor activities covering entire production and support processes
- Weighing and Dispensing verification
- Bulk Solution Preparation
- Component Preparation identification and verification
- Monitoring of In-Process Controls
- Oversight of Filling/Lyophilization activities
- Completion of Aseptic Gowning Qualification
- Finishing Activities
- Integrity Testing Verification
- Adherence of general inspection requirements/timelines
- Execution of sampling plan
- Performance of Visual Inspection (AQL)
- Packaging oversight
- Warehousing/Storage requirement adherence
- Monitoring of Facilities and Utilities per required parameters
- QA key contact to shop floor employees
- On the floor QA contact to escalate issues
- Provide real-time documentation requirements
- Troubleshooting analysis
- Participate in 5S activities
- Support in investigations & root-cause analyses
- Shop-floor documentation review of MBRs and logbooks
- Support quality and compliance and continuous Improvement projects
- Special oversight activities based on case by case demand
- Media fills
- Repackaging
- Reworking
- Validation/investigation study activities
- Other duties as assigned
- Assure compliance to SOP's
- Assure compliance to cGMP's
- Maintain the finished product reserve appropriate sampling
- Maintain FDA retention sample storage areas
- Recommend corrective action in responsible to deviations noted
- Drive a culture of continuous quality improvement
- On the shop-floor presence
- Assure that the processes required are adhered to
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