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Identify and lead application of quality tools (e.g. RCA, FMEA, CAPA) on internal manufacturing processes, customer support processes, supplier processes, and continuous improvement. We design, supply, and service a range of water systems and monitoring equipment in industries ranging from pharmaceutical to food and beverage applications, and from microelectronics ultrapure water to municipal water and industrial wastewater treatment.
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Perform Root Cause Analysis and Corrective and Preventive Action (RCA/CAPA) investigations. HACCP and/or PCQI Certification. Implement and maintain Electronic Records Program (ERP), Quality Management System (QMS), and applicable Quality Standard Operating Procedures (QSOPs) as directed by Head of QA/QC.
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Perform Manufacturing Investigations, including RCA and CAPA development and implementation. Perform Manufacturing Investigations, including RCA and CAPA development and implementation.
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Supports RCA and CAPA responses related to GMP cleaning nonconformities. The GMP/Janitorial Area Manager manages a staff for the cleaning of Critical Environments and ensures standard operating procedures are adhered to in multiple buildings.
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Directly assist the Quality Manager with QMR report preparation across the site team, including meeting coordination, record keeping and CAPA follow-up support. Track error rates, assist cross-functional team with RCA activities, and identify/implement process improvement steps.
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Act as QA reviewer for deviations and CAPA issuance; with limited approval authority as designated by QA Management. Exposure to RCA, technical writing, and working with quality related investigations.
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Perform root Cause Analysis (RCA), Client and CAPA responses. Engineering and Problem-solving tools: MINITAB, SIX SIGMA, DOE, GR&R, CAPA, CAD, DMAIC. Provide detailed engineering analysis and documentation in the management of material disposition, process updates, Client's and CAPA.
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Experience in and an advocate of a CAPA/RCA based culture to drive improvements and proactive thinking and behaviors. We have a challenging opportunity for a Manager of our Import and Export Operation based out of our JFK Airport location in Springfield Gardens, NY.
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This role will be responsible for conducting RCA, assessing impacts, and developing CAPAs to ensure efficient and effective processes across the cell and gene therapy organization. Strong technical writer with previous experience authoring, reviewing and editing risk assessment, CAPA and deviation documents.
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Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis. Knowledge of SPC, FMEA, DOE, RCA, GDT Sound knowledge of quality management systems.
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Provide technical leadership for the rapid resolution of technical issues impacting supply through product performance investigations and use of root cause analysis (RCA) tools and appropriate Corrective and Preventative Actions (CAPA) and escalate key site technical issues.
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Experience with SPC, 5S, Six Sigma, CI, RCA and CAPA. · Support RCA, 5S and Corrective Action plan to reduce quality issues, further prevent recurring issues. Report to VP of Operations and oversee the day to day manufacturing process and quality compliance on injection molding, blow molding, extrusion.
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Perform investigations of significant event deviations and/or customer complaints along with the identification of the sequence of events, impact assessment, trend evaluations, root cause analysis (RCA), contributing factors, and recommended corrective and preventive action (CAPA) plans.
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Regularly update QMS documentation to reflect changes arising from CAPA investigations and ensure continuous compliance with evolving quality system standards and regulatory requirements. Lead the initiation, investigation, and resolution of Corrective and Preventive Actions (CAPAs), ensuring thorough data analysis, RCA tools, and practical solutions to prevent recurrence while maintaining alignment with quality system and regulatory requirements.
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Assist with investigations of RCA/CAPA events. Oversee GMP compliance within cleaning, disinfectant, safety equipment inspections, work orders and pertinent tasks utilizing the client’s Computerized Maintenance Management System (CMMS.
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