Responsible for the daily measurement tasks of OMM and CMM;2. Responsible for the calibration, maintenance, and management of measuring instruments and inspection equipment;3. Responsible for managing the inventory and reports of measuring instruments and inspection equipment, and reviewing the calibration/validation results in the reports;4. Responsible for the calibration status labeling of measuring instruments and inspection equipment.5. Conduct dimension measurements for inspection requests from various departments and preserve the inspection results in electronic archives;6. After completing the measurements, prepare a report with the corresponding dimensions;7. Daily maintenance, upkeep, and inspection of measurement room equipment;[9:45 AM]Familiarity with inspection equipment is required; experience with coating thickness gauges is preferred.
Flawless Launch: Work with Manufacturing AQP or QE to conduct Safe Launch exercise,Perform process audits and reverse (go & see) FMEA’s to qualify new production processes, and to ensure compliance to documented control plans for new products.
Keeps up-to-date on regulations/ development of biopharmaceutical QC method/ technology to ensure the project maximizes the use of digitalization, automation and robotics.
Maintain quality documentation, inspection records, and compliance reports while coordinating with Production, Engineering, and Supply Chain teams on quality-related matters.
Check product markings, labels, carton markings, barcodes, and artwork provided by suppliers against approved specifications and customer requirements.