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Participate in teams for the rapid resolution of technical issues impacting supply through and product performance investigations through use of root cause analysis (RCA) tools and appropriate Corrective and Preventative Actions (CAPA), and escalate key site technical issues to the wider GMS technical community for timely resolution.
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4) Working knowledge of the quality management cycle and corrective Action/Prevention Action (CAPA) processes; knowledge of electronic clinical quality management systems such as Master Control preferred.
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Equipment, maintenance, facilities, utilities, hvac, laboratory, lab, biotech, bioreactor, freezer, biosafety hoods, manufacturing, pharmaceutical manufacturing, gmp, cgmp, calibration, troubleshooting, life sciences, capa, deviation, engineering, equipment engineering, laboratory, lab equipment, plc, cmms, blue mountain, boilers, chillers, freezers, ph meter, installation.
$40 - $50 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Report and participate in investigations of deviation, OOS/OOT results, CAPA and other related activities. Considerable expertise relevant to QC analytical methods used for cell therapy manufacturing including qPCR/dPCR, ELISA, flow cytometry or cell-based assays in a GMP environment.
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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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Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management. We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.
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We operate a state-of-the-art facility in Rockville, Maryland with five GMP suites in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies in the US.The Scientist, QC position supports the Quality Control group at AbelZeta Rockville GMP facility for IND and Phase I/II GMP manufacturing.
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Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA) BA / BS. or higher in science related field (biological science, medical, pharmacy or other health related discipline.
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Be able to develop metrics to assess validation throughput, record and follow up on non-conformances as well as CAPA from product requirement initiation to launch. Develop SDLC and associated CSV validation procedures, templates, and job aids in alignment to regulations and other compliance requirements.
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Performs change control assessments to Quality Systems including document management, change control, and CAPA. Performs change control assessments to Quality Systems including document management, change control, and CAPA.
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Conduct RCA to identify permanent fixes and update automation scripts accordingly. Description : Seeking an experienced GCP Cloud Security Engineer comfortable with remediating security vulnerabilities autonomously.
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Maintains the Quality Assurance (QA) training program, document control, customer complaint program and CAPA program. Maintains the Quality Assurance (QA) training program, document control, customer complaint program and CAPA program.
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Actively participates in and RCA meetings to identify and resolve calibration and equipment issues on a real time basis and improve business performance. Develops or guide the development of metrics and information to be used in root cause analysis (RCA) meetings.
$55 - $64 an hourFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The QC Scientist will focus on supporting the routine operation of the GMP facility in analytical development, batch release, and stability studies, etc. The role requires knowledge and experience of scientific concepts, practices, and procedures within the biopharmaceutical field and a cGMP environment.
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Preferred knowledge of Quality Systems, including deviations, CAPA, change control, and document management systems. Support quality system records, including deviations, lab investigations, OOS, CAPA and change control.
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rca capa jobs in Rockville, MD
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