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Perform analytical testing and data review of batch release, in process and/or stability samples of mRNA drug substance in cGMP compliant laboratory. Preferred 0-2 years of xperience in cGLP or cGMP lab strongly preferred.
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Bachelor’s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 8 years of experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
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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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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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Vor Bio is seeking an experienced Quality Control Senior Analyst 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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They will be able to interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Manufacturing, Logistical and Process Development Technology Transfer counterparts.
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Experience with quality systems, aseptic technique, cGMP document review, quality investigations, CAPA, Change Control and MasterControl preferred. The Quality Assurance Specialist is an intermediate level professional position responsible for quality assurance activities associated with cGMP manufacturing, documentation, and product disposition.
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Influence the organizational control of Quality Systems: Create/monitor/author deviations, Out of Specification (OOS) and Out of Trend (OOT) and unexpected events. Strong technical skills and experience in commercial biopharmaceutical Quality/Manufacturing in the areas of microbiology, environmental monitoring, microbiological testing, cell culture and/or purification, engineering or validation.
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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.
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This Quality team member will be responsible for initiating and assisting in investigations and troubleshooting while adhering to cGMP and GDP practices. 7 + years of experience in Quality Control in GMP environment.
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Strong knowledge of microbiological and sterility testing (i.e. environmental monitoring, clean room qualification and management, quality control endotoxin testing and microbiological control strategy.
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Liaise and collaborate with key stakeholders (PIER, Manufacturing Sciences, Quality Sciences, Analytical Development and Center functions) as applicable. Knowledge of cGMP and other regulatory requirements related to manufacturing of biologics and monoclonal antibodies.
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Ability to initiate, manage, and close quality systems such as change control, CAPA, and deviation management. Oversee the delivery of validation in complex, capital projects, ensuring adherence to engineering, quality, and compliance standards.
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Collaborate with CMC, Logistics, Quality Control, Quality Assurance, and Clinical Operations to develop and maintain a valid demand and supply plan, ensure the availability of products for patients, and support the company’s business objectives.
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cgmp quality control jobs in Cambridge, MA
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