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Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system. Perform review of release, stability, validation, analytical quality control tests on raw materials, in-processing and final products.
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The Scientist, Analytical Development & Quality Control is responsible for analytical development, feasibility, method qualification, routine, and stability testing of antibody drug conjugates and intermediates.
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Oversee cGMP contract testing, including review and approval of analytical methods, method validations, specifications, qualification, and stability programs at CROs and CMOs. Ensure Quality Control related documentation (QC test methods, analytical validation and/or qualification, reference standard program, and stability studies) meet ICH [International Conference on Harmonization] and other regulatory guidelines.
$140,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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A minimum of 3-5 years in Analytical Development and/or Quality Control preferably in a clinical stage biopharmaceutical company. Experience working with CDMOs and external QC vendors.
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Plan, direct and coordinate QC batch record review, logbook review, QC test review, and lot disposition activities. Serve as a leader within the QC group and as a knowledge resource (data review, electronic review, data integrity, GDP) within the company.
$119,500 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The QC Analyst II – Biochemistry will primarily focus on daily lab operations and execution of testing to support manufacturing operations, validation, or development studies. Job Title: QC Analyst II – Biochemistry.
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Manage and develop the team responsible for the Quality Control Raw Materials program, the QC Raw Materials Testing Laboratory and outsourced raw material testing labs. BS in a scientific discipline with 8 years’ experience in pharmaceutical / biotech industry within Quality Control or Quality Assurance, at least 4 years managing QC Testing Laboratory.
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The Senior Analyst / Scientist will work cross-functionally with others in Quality Control, Analytical Development teams, Quality Assurance, and Manufacturing, as needed. The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs) and analytical assays for AAV efficacy (potency), safety and product quality.
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About SIS at Pace Like Pace, our customers are continually innovating and looking for quality candidates to support their important work. Support qualification and validation testing of QC methods in area of expertise.
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Provide technical support for control systems throughout the facility, including quality control instruments, clean utilities, process development equipment, GMP manufacturing systems, and the building automation system.
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The Alloy Global Bioanalytics group provides bioanalytical support to all Alloy activities, including assay development, quality control and high-throughput characterization of antibodies, TCR mimics and other modalities.
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IT CSV project engineer's IT System Administrators and System Owners and Quality Assurance on projects including clinical data repositories master data management. Assess change controls for impact to validated computer systems and participate in corrective and preventive actions (CAPA) and other Quality Management System (QMS) activities.
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The QC Associate will support cellular therapy product release testing within the QC analytical laboratory at our BaseCamp facility in Waltham. Bachelor’s, or Master’s, degree in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 3-5 years of experience, or 2-3 years with Master’s degree, preferably in a GMP QC laboratory setting.
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Acting as a one-man attachment to other special forces teams, these highly specialized Airmen are trained in a wide range of skills, including scuba, parachuting and snowmobiling, as well as being FAcertified air traffic controllers in order to establish air control and provide combat support on missions all over the globe.
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O Lead and support QC deviations, investigations, CAPA, Change control, analytical method performance trending and root cause analysis, as needed. The Senior Analyst/ Scientist, Quality Control Chemistry, will support external laboratory testing and internal study protocol design, study report review and IND support as needed.
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quality control qc jobs Title: project manager in Bedford, MA
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