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Minimum of 6 years of experience in drug safety/pharmacovigilance quality assurance or compliance within the pharmaceutical or biotech industry. Certification in pharmacovigilance (e.g., RQAP-GLP, PVQA) or quality management (e.g., ASQ Certified Quality Auditor) is a plus.
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Drive the adoption of best practices for data quality and integrity. Understanding of nucleic acids DNA/RNA analytical performance assessment tools: PCR, Cloning/plasmid generation and design, Quality control on DNA/RNA (capillary electrophoresis, UV quantification, Sanger sequencing, NGS.
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The selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
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Professional Requirements:Proven experience (5+ years) in supervisory quality management roles within manufacturing of biologicals, preferably in Ag-Biotech and/or fermentation industryPh. D. in Analytical chemistry or biochemistry with at least three (3) years of experience beyond the Ph. D.Certification in Quality Management (e.g., ASQ Certified Quality Manager, Six Sigma Black Belt.
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ElevateBio is looking for a Cell Therapy Manager, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Manager will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events.
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Record patient data to Tech Data Entry program. Forward data and or films/CD to Radiologist upon completion of exam. Shields Health has an exciting opportunity for an X-Ray Tech (or MRI Tech Trainee) to work Full-Time at various locations (Framingham (Mon/Wed), Brockton (Tues), Brighton (Thurs) and Dartmouth (Fri) 7:00 - 3:30pm.
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Veralto's Water Quality companies-Aquatic Informatics, ChemTreat, Hach, McCrometer, OTT HydroMet, Sea-Bird Scientific, Trojan Technologies and XOS-help manage, treat, purify, and protect the global water supply, from municipal and industrial wastewater treatment facilities to lakes, rivers, watersheds, and oceans.
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Requirements Masters degree in a relevant technical field Extensive practical experience with spaceborne, airborne, and/or UAS-based remote sensing platforms and data sources, including lidar, synthetic aperture radar, and hyperspectral data sets is required.
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Your job,asData Historian Engineer (OSI PI) IIIwithin our Digital Engineering team,will be to provide data historian expertise for projects including continuous improvement, retrofit, and large capital investments to optimize manufacturing and supporting operations.
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Substantial experience with at least one major category of 3D data, such as CAD, CAM, graphics, 3D scanning, simulation of 3D physical phenomena, mechanical-interacting control system design and modeling.
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Reporting to the Field Operations Manager, Quality Assurance Inspectors partner with HPC's, residential customers, and Abode office staff to ensure that work completed under the Mass Save program meets program standards, is high quality, and delivers a great customer experience.
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As the Quality Assurance Lead, you must possess a strong background in Quality Systems, Document Control, Supplier Quality, and Validation within the biotech industry. Demonstrated experience with Quality Systems, Document Control, Supplier Quality, and validation activities.
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Apply and instruct others in the use of Quality systems (CAPAs, change control, measurement systems and Analysis (MSA), Statistical Analysis, Control Plans, document management, etc) Coordinating and serving as the contact with all external contract organizations including key domestic and international vendors, contractors, or service providers, including but not limited to CMO's, CRO's, Labs, consultants, testing facilities, auditors, and/or advisors related to quality aspects of GxP related expectations.
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The Cardiac Sonographer / Echo Technologist job requires the sonographer to utilize color-flow duplex ultrasound to produce ultrasound images and related data, which is used by physicians to render a medical diagnosis.
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As such, you will provide scientific input into design & implementation of clinical trials, their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA.
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data quality jobs Title: data Company: Ctg in Wayland, MA
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