MQA Specialist I
$60,966–$85,694 year
On-siteWilson, North Carolina, United States
Job Summary
Oversee production quality by verifying weighing and dispensing, monitoring in-process controls, and supervising filling, lyophilization, and finishing activities including integrity testing and visual inspections. Ensure compliance with SOPs and cGMPs by maintaining finished product reserves, executing sampling plans, and performing AQL packaging oversight. Act as the on-floor QA contact to escalate critical deviations, support root-cause analyses, and drive continuous improvement projects. Review shop-floor documentation for GMP adherence and participate in validation and investigation studies. Participate in 5S activities and provide real-time troubleshooting analysis.
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 and cGMP's
- Maintain the finished product reserve appropriate sampling and 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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