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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 root Cause Analysis (RCA), Client and CAPA responses. Provide detailed engineering analysis and documentation in the management of material disposition, process updates, Client's and CAPA.
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Experience with use of complex Root Cause Analysis (RCA) tools and methodologies, research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus. Minimum of 4 years working within quality systems managing deviations and CAPA.
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Use industry best practices to solve engineering problems using analytical methods such as 8D RCA, DOE, and apply statistical analysis for product improvements and apply FMEA process to implement sound engineering solutions.
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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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Leads problem solving events and process improvement initiatives using RCA and CAPA tools. Leads problem solving events and process improvement initiatives using RCA and CAPA tools. We are looking to hire an QA Manager II immediately out of our Distribution Center in Sparrows Point, Maryland.
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Engineering and Problem-solving tools: MINITAB, SIX SIGMA, DOE, GR&R, CAPA, CAD, DMAIC. Engineering and Problem-solving tools: MINITAB, SIX SIGMA, DOE, GR&R, CAPA, CAD, DMAIC. Application of statistical and analytical methods such as SPC, SQC and DOE.
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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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Lead and support all regulatory and GMP certification inspections and audits as they occur and oversee the completion of any follow-up/action items with oversight from Head of QA/QC. Coordinate and lead annual Food Safety and Food Defense reviews and exercises and oversee the completion of any follow-up/action items with oversight from Head of QA/QC.
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Responsible for investigating quality matters by leading RCA meetings in the CAPA process, assisting with CAPA plan implementation and Effectiveness Checks. Ability to wear required laboratory clean room clothing (laboratory coats, hair bonnets, and beard covers (as applicable) and other safety/protective equipment (masks, gloves, and/or face shields for example) for up to two and a half hours consecutively.
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Experience with Process Improvement and/or Continuous Improvement practices (e.g., Kaizen, DMAIC, Gemba, DOE, Root-Cause Analysis (RCA), etc.) Strong analytical skills with proven experience working with a variety of Quality tools (FMEA, 8D, CAPA, 5Why, etc.
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Contribute quality and compliance expertise and guidance to CAPA owners responsible for addressing specific quality issues to ensure robust investigations are conducted for CAPA with established root cause analysis (RCA), action plans and documented effectiveness criteria to assure full and effective closure without repeat CAPA.
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Knowledge of quality tools RCA/Fishbone/Lean/Six Sigma/Industrial Engineering Experienced in line setup. Investigate quality issues, ensure effectiveness of CAPA and validate vendor/factories are driving toward continuous improvement.
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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 to ensure rapid resolution of technical issues impacting supply through robust investigations, leveraging root cause analysis (RCA) tools and developing appropriate Corrective and Preventative Actions (CAPA.
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