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Quality Control and/or Analytical Development experience in Biotech, cGMP areas. We are looking for a Quality Control (QC) professional to join our team as a Senior Quality Control Analyst, supporting our internal GMP cell therapy manufacturing.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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QA | Quality Assurance | Quality Control | cGMP | AAV Gene Therapy | CDMO | Biologics Manufacturing | Quality Operations | Quality Systems | FDA | CGT | Cell and Gene Therapy. Expert knowledge of cGMP regulations.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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The incumbent will work cross-functionally with colleagues from Manufacturing, Manufacturing Science and Technology, Global Engineering, Validation, Process Engineering, EM/UM Quality Control, CMC Regulatory, and Quality Operations on the design of processes and technologies required to produce aseptic drug product to successfully commercialize an exciting and diverse portfolio of innovative cell and gene therapy pipeline programs.
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Vor Bio is seeking an experienced Quality Control Analyst II/Senior Analytst to be a part of the team responsible for the day-to-day operations assigned to the QC Microbiology group, including sampling of a cGMP manufacturing facility, testing samples in the QC Microbiology laboratory for batch release of advanced therapeutics including cellular and gene therapy products.
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Advanced working knowledge of cGMP compliance requirements for pharmaceutical analytical development and quality control laboratories. The Manager, Quality Control has responsibility for actively overseeing cGMP quality control activities associated with development and commercialization of the company’s small-molecule assets.
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Serve as QA lead for quality system elements including Document Control, Training, Deviation Management, Internal and External Inspection, Supplier Management, Risk Management, Complaints, Recalls, etc.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Quality Management Systems (including complaint management, CAPAs, deviations, change control, quality audit management, supplier quality management, etc.) In addition, our team also works on projects with clients to manage these Quality business processes for supply chain, manufacturing, commercial operations and R&D. This includes analyzing various cGMP and 21 CFR Part 11 regulations in the Regulatory Compliance area to determine impact on risk exposure.
$82,800 - $136,600 a yearFull-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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This role is instrumental in executing our current supply planning and in helping us develop and implement our future capabilities There role collaborates closely with Process Development, Research, CMC, and Quality Control and Quality Assurance.
Full-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Good understanding of cGMP, GLP, and FDA requirements for maintenance. building monitoring and control systems (BMS/BAS). Wastewater Treatment Plant Operator License desired. Good understanding of cGMP, GLP, and FDA requirements for maintenance.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience with quality systems, aseptic technique, cGMP document review, quality investigations, CAPA, Change Control and MasterControl preferred. College Degree and at least five to eight years cGMP experience in a pharmaceutical manufacturing company or equivalent combination of education and cGMP experience in a required.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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A Bachelor's degree in a relevant scientific discipline or equivalent Quality Control experience in a cGMP organization with a focus in Microbiology. Complete documentation in accordance with current Good Manufacturing Practices (cGMP) ensuring data integrity.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Demonstrated ability to lead and/or author investigations to determine root causes of OOTs and/or OOSs according to cGMP standards required. The Quality Control Analyst compiles data for documentation of test procedures that may include stability program testing and formulation studies, participates in the preparation of investigations, summaries and reports, and reviews data obtained for compliance to specifications and reports out-of-trend and/or out-of-specification results.
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Previous experience working with quality systems overseeing cGMP production operations including batch release, SAP, batch record review. Maintain quality systems including Change Control, CAPAs, Deviations, Self-inspection auditing, QA reporting, and approval of GMP documentation.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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The Senior QC Analyst ensures quality control through analytical testing, method validation, and compliance with SOPs, playing a pivotal role in releasing cell therapy products. Experienced in gene therapy practices, with a focus on manufacturing, testing, and cGMP compliance.
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cgmp control jobs in Cambridge, MA
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