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A minimum of 8 years in Analytical Development and/or Quality Control. Support establishment of critical quality attributes, specifications, and trend stability data to establish expiry dating of DS and DP.
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Experience developing quality control plans, supplier quality audits, failure analysis, and root cause corrective actions. 2 or more years of related experience in Manufacturing and/or Quality Engineering.
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Develop control system architecture, selecting the components to be used, detailing schematic diagrams and system documentation, programming controllers (PLC, DCS, RTU), programming the process visualization (HMI/SCADA), developing databases for archiving/displaying historical system data and implementing/commissioning the control system at the client’s facility.
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Participate in continuous improvement of laboratory safety and quality compliance. Executes routine procedures based on biochemistry methodologies, such as HPLC, UPLC, SoloVPE.Execute routine procedures based on bioassay methodologies, such as plate-based assays (ELISA, ddPCR, ribogreen), gel electrophoresis, western blot and cell based assays.
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Works in collaboration with all clinical departments, Medical Staff, Health Information Management, Information Technology, Occupational Health, Infection Control, and Institute for Aging Research to support quality initiatives for HRC. Exercises discretion in maintaining the confidentiality of documents and information.
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Vor Bio is seeking a Quality Control Senior Analyst who will be responsible for executing activities related to establishment / release / testing of raw materials to support GMP manufacturing activities as well as maintaining critical laboratory materials.
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Establish, Maintain and Improve GxP Quality System including, but not limited to: Deviations, CAPA, Change Control, Risk Management, Inspection Readiness, Product Complaints, Recall/Mock Recall, Internal Audit/Self-Inspection, Supplier Quality Management (incl AVL, QAG and Audit Management), Auditor Qualification, OOS/OOT, CSV, Data Integrity, Training and Document Control.
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The Vertex Cell and Gene Therapy (VCGT) Type 1 Diabetes (T1D) Quality Control (QC) team is responsible for the testing of samples and associated workflows within our stem-cell based T1D program.
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The Manager is a hands-on manager that can organize and lead a team of QC personnel, support and execute QC testing, and contribute significantly to overall Quality Control strategy The ideal candidate will have experience working in a GMP QC laboratory setting, experience with cell and gene therapy test methodologies, compendial safety testing and enjoy a fast-paced, collaborative, and vibrant startup culture.
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CFS is seeking an experienced Quality Inspector to lead inspection and test activities for the SPARC project. Interface with Technicians on issues related to quality and help them in understanding and interpreting quality specifications and technical drawings.
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We are looking for an experienced Quality Control (QC) professional to join our team as Manager QC Systems, supporting our internal GMP cell therapy manufacturing. 10-12+ years of relevant biotech/pharma industry experience, including Quality Control experience supporting cGMP areas.
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Title Postdoctoral Fellow in Biomedical Control. Harvard is part of a collaborative consortium of researchers that includes NYU , UCSF , Mt. Sinai School of Medicine, the Institute for Systems Biology, and the Army Center for Environmental Health Research.
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The Sr. Director, Quality Assurance will be responsible for implementing GxP (GCP/GLP/GMP) compliant Quality Management Systems, performing all required functions of the Quality Unit (ie product release) and building a Quality Assurance organization that fosters a strong Quality culture at Be Bio. This position will partner equally with both internal and external stakeholders and partners (CROs, CDMOs.
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The Endoscopy Center Processing Technician is responsible for the leak testing, manual cleaning, and high level disinfecting of all endoscopic equipment and accessories according to infection control guidelines and established Endoscopy Center guidelines.
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Associate Director, Analytical Development/Quality Control Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.
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quality control jobs Title: quality control analyst in Cambridge, MA
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