Interesting, based on Jason Flores background is Q
Post# of 22444
(Total Views: 394)
Posted On: 08/15/2022 12:59:43 PM
Interesting, based on Jason Flores background is QMC in the process to manufacture something?
" Implementation and oversight of the following: deviation management, batch record review, manufacturing quality, incoming quality, and compliance quality. Ensure appropriate tracking and timely resolution of quality issues (deviations, CAPAs, and change controls). Ensure timely review/approval of basic and technical documentation to include but not limited to, Commissioning/Qualification/Validations (CQV), standard operating procedures (SOPs), work instructions, batch production records, QC data review and approval. Provide support of regulatory inspections, customer and internal audits. Maintain visibility and investigate regulatory compliance requirements, guidelines, and trends. Ensure appropriate organization controls on in-process documentation. Site trainer for GMP compliance."
"Responsible for daily management of quality systems including but not limited to quality oversight of the manufacturing areas. Review and approval of work orders, protocols, qualifications, commissioning, validations, change controls. Assist with deviations including scope, impact, and associated corrective actions. Implementation and management of quality assurance processes, procedures, and best practices. Follow GDP (Good Distribution Practices) on all shipments and may be asked to be GDP representative for logistics. Responsible for personnel management including hiring, development, and performance management. Site trainer for compliance Good Documentation Practices (GDocP)."
"Provide oversight in manufacturing and packaging areas, incoming material inspection/approval, validation, deviations, commissioning and qualifications of facilities, equipment and processes, review and disposition of batch records and packaging records. Clearly communicate complex issues to management personnel. Ability to make independent decisions regarding quality related concerns or issues. Manage KPI's and metrics on a regular basis in order to meet release scheduling. Ensure that current procedures are followed in connection with handling of complaints and recalls, returned goods, reprocessing and environmental monitoring. Assist in analysis of inspection rejects; assist in root cause analysis and implementation of CAPAs. Collect data for monthly and annual product review. Perform and document assessments of aseptic behavior inside the aseptic manufacturing area during compounding, filling, capping, and lyophilizer loading/unloading activities. Provide real time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation."
"Monitor manufacturing processes and personnel to assure compliance with Standard Operation Procedures (SOPs) and cGMP compliance, persued resolution to issues as they arise with a quality risk assessment mindset on decision making, manage quality engineers and inspectors in a manufacturing environment. Hire, train, supervise, evaluate, and develop MQ employees, interfaced with operations, materials management, engineering, and other various departments to resolve issues and or determine if an exception report (ER/CAPA) is needed, conducted and prepared ER/QAR/CAPA investigation reports, manage projects to ensure completion within the required time schedule as required per quality systems, authored re-inspection plans and provided quality oversight during re-inspection to assure samples are within specification limits, partner with manufacturing to track and trend metrics and assist with continuous improvement, safety training to manufacturing and quality departments, effectively communicated in all directions as part of a leadership role."
"Provided quality oversight in manufacturing areas (dry/wet) for SOP and cGMP compliance, shift walkthrough specific person of accountability, reviewed batch records, completed FDA audited investigations using the DMIAC process, assisted with audits of internal/external processes, reviewed equipment/cleaning logbooks for impact to quality, performed data analysis to validate processes, edited/reviewed/revised SOPs, worked with cross functional teams to prevent/remediate deviations, completed safety inspections of processes/facilities/colleagues, monitored processes using SPC, M1 training (Pfizer lean manufacturing, yellow belt), trained Quality Engineers/colleagues/supervisors (QFE), coordinated projects, application development, PDA certified in sterilization processes, continuous improvement, special projects as the arise. "
" Implementation and oversight of the following: deviation management, batch record review, manufacturing quality, incoming quality, and compliance quality. Ensure appropriate tracking and timely resolution of quality issues (deviations, CAPAs, and change controls). Ensure timely review/approval of basic and technical documentation to include but not limited to, Commissioning/Qualification/Validations (CQV), standard operating procedures (SOPs), work instructions, batch production records, QC data review and approval. Provide support of regulatory inspections, customer and internal audits. Maintain visibility and investigate regulatory compliance requirements, guidelines, and trends. Ensure appropriate organization controls on in-process documentation. Site trainer for GMP compliance."
"Responsible for daily management of quality systems including but not limited to quality oversight of the manufacturing areas. Review and approval of work orders, protocols, qualifications, commissioning, validations, change controls. Assist with deviations including scope, impact, and associated corrective actions. Implementation and management of quality assurance processes, procedures, and best practices. Follow GDP (Good Distribution Practices) on all shipments and may be asked to be GDP representative for logistics. Responsible for personnel management including hiring, development, and performance management. Site trainer for compliance Good Documentation Practices (GDocP)."
"Provide oversight in manufacturing and packaging areas, incoming material inspection/approval, validation, deviations, commissioning and qualifications of facilities, equipment and processes, review and disposition of batch records and packaging records. Clearly communicate complex issues to management personnel. Ability to make independent decisions regarding quality related concerns or issues. Manage KPI's and metrics on a regular basis in order to meet release scheduling. Ensure that current procedures are followed in connection with handling of complaints and recalls, returned goods, reprocessing and environmental monitoring. Assist in analysis of inspection rejects; assist in root cause analysis and implementation of CAPAs. Collect data for monthly and annual product review. Perform and document assessments of aseptic behavior inside the aseptic manufacturing area during compounding, filling, capping, and lyophilizer loading/unloading activities. Provide real time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation."
"Monitor manufacturing processes and personnel to assure compliance with Standard Operation Procedures (SOPs) and cGMP compliance, persued resolution to issues as they arise with a quality risk assessment mindset on decision making, manage quality engineers and inspectors in a manufacturing environment. Hire, train, supervise, evaluate, and develop MQ employees, interfaced with operations, materials management, engineering, and other various departments to resolve issues and or determine if an exception report (ER/CAPA) is needed, conducted and prepared ER/QAR/CAPA investigation reports, manage projects to ensure completion within the required time schedule as required per quality systems, authored re-inspection plans and provided quality oversight during re-inspection to assure samples are within specification limits, partner with manufacturing to track and trend metrics and assist with continuous improvement, safety training to manufacturing and quality departments, effectively communicated in all directions as part of a leadership role."
"Provided quality oversight in manufacturing areas (dry/wet) for SOP and cGMP compliance, shift walkthrough specific person of accountability, reviewed batch records, completed FDA audited investigations using the DMIAC process, assisted with audits of internal/external processes, reviewed equipment/cleaning logbooks for impact to quality, performed data analysis to validate processes, edited/reviewed/revised SOPs, worked with cross functional teams to prevent/remediate deviations, completed safety inspections of processes/facilities/colleagues, monitored processes using SPC, M1 training (Pfizer lean manufacturing, yellow belt), trained Quality Engineers/colleagues/supervisors (QFE), coordinated projects, application development, PDA certified in sterilization processes, continuous improvement, special projects as the arise. "
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