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Senior Representative, QA
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Full-time
- Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients.
- Quality Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, supplier quality management, raw material testing and disposition, and training, as well as oversight of the equipment calibration and preventive maintenance program and validation activities.
- Quality Assurance Operations group has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping.
- Maintains the equipment master data in the Computerized Maintenance Management System (CMMS)
- Generate or revise GMP documentation such as Standard Operating Procedures, Master Batch Record review, etc.
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