Urgent Hire Quality Assurance Supervisor
Confidential - irvine, CA
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Responsibilities for QA supervisor• Train the Lab technicians in the different quality and reliability testing• Coach the Lab Self-directed team• Make sure the lab equipment's and fixture are maintained in good conditions, following up the maintenance and calibration plans• Develop and execute the annual requalification plan• Interact with his PLT Lab partner worldwide working like a team to achieve the expected results• Very good Interaction with the internal customers in NPD and Sustaining• Measure the performance of the lab regarding critical KPI's as• Support external and internal regulatory and compliance audits and inspections• Assist in the generation and authoring of product and process discrepancies (and associated investigations and dispositions), as documented via non¬conformance, deviation• Ensure adequate support to all release system users (training, improvement, issues,...)Qualifications for QA supervisor• Able to perform functions in accordance with cGMP guidelines• Individual may be required sit for extended periods• Bachelor's degree in a science discipline with 3 years' experience in Pharmaceutical Quality or Manufacturing, or bachelor's degree in non-science discipline with 6 years of Pharmaceutical Quality or Manufacturing experience• Knowledge of aseptic manufacturing processes preferred• Must wear appropriate PPE as required for various manufacturing areas• Supports Plant Management with Technical changes such as new formulas, reformulation changes, packaging, equipment, and processes• Develop and Issue line specification sheets with core weights, dimensions, coating, finished bar weights, visual aids, to Operations & Quality personnel• Interacts with all Plant Departments, Suppliers, Corporate, governmental agencies, and external auditors• Provides back-up to Quality Manager on all key functions• Direct, coordinate and schedule the activities of QA personnel to proactively respond to plant production needs• Develop andor assist in developing quality programs and procedures as required• Coordinate and maintain Master Control Documents, quality data collection, charting, trending, and reporting projects• Assures efficient and accurate testing, reporting, and monitoring of product safety and quality• Participation in corporate-driven projects, tests, reports, and data collection• Anticipate and solve quality-related issues through evaluation of ingredients, materials, process, and finished productsQualifications for QA supervisor• Experience in development methodologies and types of testing (e.g., Functional, System Integration, Regression )• Working knowledge in all construction disciplines• Bachelor's degree in a Scientific Discipline or equivalent related experience. Strong knowledge of GMPs and their application• Strong statistical and mathematical aptitude• Understanding of Statistical process control preferred
Created: 2025-02-22