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Quality Assurance Lead for the cross-functional CMC Sub-Teams. The Director, CMC QA will report to the Executive Director of CMC QA and be responsible for maintaining strategic responsibility over QA Operations, developing and implementing Ultragenyx CMC Quality approach for assigned Gene Therapy programs, and working with colleagues to improve processes utilized to ensure product quality.
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Cambridge Isotope Laboratories (CIL) has an outstanding opportunity for a Quality Assurance Specialist I to join the team responsible for the quality of several new and existing active pharmaceutical ingredients (APIs) and medical device components based onsite in our Tewksbury, MA location.
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The Quality Control Analyst I (RP/ISO) is responsible for conducting routine analysis of materials including: Raw Materials, in-process and finished formulations under general supervision and in accordance with standard operating procedures (SOPs.
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Work with Sarepta Quality assurance to draft and approve method, reference standard, qualification, and validation reports. The Associate Director of Quality Control - Nucleic Acids Testing will be responsible for overseeing a laboratory charged with the execution of all GMP Nucleic Acids Tests (release and stability) related to Sarepta's Gene Therapy pipeline.
$156,000 - $195,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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In this role, you will be responsible for the quality control review of scientific documents within the Translational DMPK and Clinical Pharmacology group. Conduct Quality Control (QC) review of Bioanalytical data (LC-MS/MS, ELISA, qPCR, etc.
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The individual will devise, troubleshoot, and validate cell-based assays to assess the critical quality attributes of AAV gene therapy products including potency and infectivity. Author and review quality documents such as SOP, OOS/OOT, CAPA and Change Control originated internally as well as at the vendor sites.
$96,000 - $120,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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BS with 5+ years in biopharma Quality Assurance (Extensive experience within GLP or GCP preferred) Job Overview: Our client is looking to add an Associate Director of Quality Systems to support and expand on the quality management systems and processes and be a key stake holder in driving the quality culture including GCP and GLP compliance.
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Location Information:This position is a remote assignment as a Field Supplier Quality Engineer residing in the Northeast, Midwest, or Southeast region. Job Summary :The Field Supplier Quality Engineer (FSQE) is the primary quality interface between Raytheon’s organization and the external supply base.
$77,000 - $163,000Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Quality certifications like ASQ Six Sigma Green Belt or Black Belt, CQE, etc. Job Title: Quality Systems Engineering Manager. Excellent knowledge of Quality Management System (QMS) in high volume semiconductor, or electronics manufacturing environment.
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Title: Inspection - Contractor - D (Quality Tech + CMM programmer) Work closely with the program team to ensure quality standards are consistently met and maintained. Collaborate with cross-functional teams to continually improve quality processes and standards.
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Must have working knowledge of tools & technical processes including identity & access management, database management; software development and quality assurance methodologies, change management, vulnerability management, penetration testing, data loss prevention, batch processing, business continuity/disaster recovery planning; enterprise architecture, telecommunications, data center operations, etc.
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Inspection, Quality control, clean room, Quality inspection, Calipers, Visual inspection, Qc, Micrometer. Inspection,Quality control,clean room. Qualifications High school plus 1-3 years of related experience in inspection Experience with medical devices Clean room experience is a plus Familiarity with Quality Systems is preferred.
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A Document Quality Control Specialist position (fully remote) is now available through Adecco Medical and Science. Working knowledge of bioanalytical assays (LCMS/MS, immunoassays, etc.) Demonstrated proficiency with LIMS/LabVantage and sample management is a plus.
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This is a fully remote position, but you MUST be located in the Northeast. Check DMPK trackers for accuracy of entries and consistency of use. This position will report to the Sr. Manager, QC and Sample Management.
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Participate in continuous improvement (Six Sigma Black Belt and lean manufacturing projects) within assigned manufacturing areas; develop, analyze, and report statistical data, relative to quality systems performance and implementation; support and maintain failure analysis process.
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Title: quality assurance auditor Company: Inotiv in Tewksbury, MA
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