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Direct and support employee training, SOP creation and continual process improvement objectives
Reviews batch records and perform product release activities
Coordinates QC testing including sample submission and testing result review.
Manage calibration program and record keeping
Coordinates and leads Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition
Coordinates the review and revision of procedures, specifications and forms to maintain and improve the QMS
Collaborates with APAC Regulatory team to compliance activities including regulatory approvals
Perform routine cleanroom monitoring activities, including airborne particle monitoring and differential pressure checks, to ensure compliance with environmental and operational requirements.
Performs investigations and analysis activities to support resolution of quality issues
Col...