ClinLab Staffing
Quality Assurance Supervisor at ClinLab Staffing Windsor, NJ
ClinLab Staffing, Robbinsville, New Jersey, United States
Quality Assurance Supervisor job at ClinLab Staffing. Windsor, NJ.
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 fixtures are maintained in good conditions, following up the maintenance and calibration plans Develop and execute the annual requalification plan Interact with PLT Lab partner worldwide to achieve the expected results Provide very good interaction with the internal customers in NPD and Sustaining Measure the performance of the lab regarding critical KPI’s 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 to 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 and/or 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 products 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
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Train the Lab technicians in the different quality and reliability testing Coach the Lab Self-directed team Make sure the lab equipment’s and fixtures are maintained in good conditions, following up the maintenance and calibration plans Develop and execute the annual requalification plan Interact with PLT Lab partner worldwide to achieve the expected results Provide very good interaction with the internal customers in NPD and Sustaining Measure the performance of the lab regarding critical KPI’s 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 to 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 and/or 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 products 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
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