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QA, quality assurance, cell therapy, gene therapy, CAR-T, cell and gene therapy, cell culture, mammalian cell culture, investigation, deviation, CAPA, non conforming, batch record, batch record review, technical writer, quality control, medical, dental, vision, 401k.
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Xilis is looking to hire a Sr. Quality Assurance Specialist to support the further development of the Quality & Compliance programs. Manages, tracks, and reports status of Quality Systems programs including Deviation Management, Corrective Action and Preventive Action (CAPA), Change Control, and Quality Risk Management.
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In addition, the individual will collaborate with Quality Assurance, IT, Manufacturing, and other cross-functional teams as required. This includes performing analytical methods, data review and trending, and implementation of GMP operational support systems ensuring a compliant Quality Control lab.
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We create the foundation on which Durham is built, using innovative methods that support the City's growth and enhance our quality of life. Are your studies within the Departments of Interdisciplinary Studies, Communication Arts Concentration; Mass Communications, Media Studies Concentration; or English, Writing Concentration.
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Work closely with Analytical Development, Quality Control, Quality Assurance, Production and any other relevant departments. Support other Analytical Development and quality control initiatives as needed, including but not limited to streamlining documentation, creating/updating SOPs, stability program, etc.
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Develop, coordinate, and execute strategies related to equipment relocation, modification, and updates, ensuring GMP compliance by working with team leaders including validation, engineering, asset owners and quality assurance.
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A minimum of 6 years' experience in pharmaceutical, medical, device, biotech, or clinical trial contract research industry, including minimum 2 years' experience in Quality Assurance and/or Regulatory Compliance/Affairs.
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Data modeling, quality, analysis, profiling (working experience with any data quality tool, SAS, Ataccama, Informatica Data Quality, Talend, OpenRefine) Accountable for the quality control (through validation and verification) of mapping specifications to be industrialized by data engineering and maintained in platform provisioned tooling.
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Familiarity with GxP Manufacturing Guidelines and/or GxP Quality Control / SCADA, Quality Assurance Experience Lab Equipment, Infrastructure. CGI is seeking a seasoned MES software quality engineer to join our growing team supporting life science clients through end to end solution offerings and professional services.
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Strong knowledge of GMP quality systems. Assist in oversight in transition of automated equipment to comply with regulatory and quality control requirements. Experience with automation platforms including Allen-Bradley PLC, DeltaV DCS, Beckhoff TwinCAT PLC and/or Johnson Controls.
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Wolfspeed is seeking a proven, hands-on Semiconductor Quality Engineer to proactively lead the Manufacturing Quality function for Wolfspeed silicon carbide wafer manufacturing in the Raleigh/Durham area of North Carolina.
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Flexibility for domestic and international travel· Spanish language fluency is a plusDesired general experiences or exposures through completed classwork or work experience include hydrologic, hydraulic, watershed and/or reservoir model set up, calibration, and assessment/interpretation; spatial, time series, and generalized data collection, organization, quality assurance, and interpretation; and project documentation and report writing.
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Accountable for the quality control (through validation and verification) of mapping specifications to be industrialized by data engineering and maintained in platform provisioned tooling e.g., models, schemas, controlled vocab.
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May deliver CMC regulatory strategy to support major inspections (eg PAIs) or quality incidents (PIRCs). Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies and systems to enhance the efficiency and quality of departmental work Comfortable taking opposing views/position and can do so assertively, but not aggressively and can provide rationale for position with data/precedent/guidance; evaluates data and environment objectively.
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The QA Data Steward serves as a power user and quality data steward for IDS systems supported by Quality Assurance including LIMS (Darwin), MES(PMX), SAP, TrackWise, and Veeva Quality Documents.
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quality assurance jobs Title: supplier quality assurance in Durham, NC
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