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The Sr Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as varied vendors supporting Clinical Studies.
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About the Job The Molecular Technologist II position is a key member of the clinical diagnostic laboratory operationsstaff responsible for performing all aspects of complex patient sample testing, solution and reagentpreparation, equipment maintenance and tasks that pertain to the handling and testing of patientspecimens.
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Lead and manage commercial QA oversight program including manufacturing, packaging and labeling, serialization, direct to practitioner sample program, third party logistics activities, to ensure compliance with DCSCA and associated regulatory requirements.
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Utilize the Laboratory Information Management System (LIMS) to track and execute sample processing. The Molecular Technologist I performs procedures in a complex patient sample testing process with limited supervision.
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Responsible for establishing the QC GMP laboratory and operational systems at the Sanofi Waltham site, including instrument IQ/OQ/PQ, analytical transfer, SOPs readiness, laboratory operations system, sample and reference/reagent management, shipping, etc.
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Reviews study sample metadata to confirm consistency between the tube labels, study paperwork and electronic sample management systems (eSMS) The Sample Management Technician is responsible for GxP-compliant processing of incoming samples and reference materials.
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Ability to operate PCR apparatus, including managing sampling schedule, sample preparation, managing consumables inventory, data management and results interpretation. Ability to perform all microbiological testing operations on wort & beer, including yeast cell counting, pitch rate determination, microbiological media preparation, sample collection using aseptic technique, microbiological screening of yeast, wort & beer samples, sterile filtration of beer samples, assistance with barrel sampling projects and yeast propagation as needed.
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In this role you will assist with QC data trending projects, sample/reagent inventory management, and LIMS master data. Reporting to the Manager of QC Logistics, he/she assists in developing tools to improve management of sample and/or reagent inventory.
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Assist in QC sample management for internal and external testing samples. Capable of completing assigned responsibilities under minimal supervision and keeping management informed of work status.
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Manage operational aspects of the QC laboratory including scheduling of GMP testing, stability studies and logistics, sample management and the critical reagent program. Experience in supporting or leading laboratory operations such as logistics for GMP manufacturing, logistics for stability testing, management of sample inventory and/or management of critical reagent program.
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The primary responsibility includes clinical trial sample management for 4+ clinical trials with novel therapeutics currently undergoing testing in oncology patients. Clinical Trial Sample Management Responsibilities.
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We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally.
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For nearly two decades, our expert scientists, engineers and business innovators have provided scientists with world-leading, innovative solutions for liquid handling, sample preparation, and sample management that help accelerate research and make a real difference to human health.
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Painting / Marking / Coating Units / Touch up painting Installing Helicoils Applying irridite (Chromate conversion) ESS related tasks (loading overs, burn-in, thermal shock and vibration) Seam sealing Feed thru replacement Weekly sample testing Ability to support production as required.
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Process compound requests with accuracy and efficiency using automated workflows, liquid handling tools, and sample management systems, supporting high-throughput screening (HTS) and hit-to-lead efforts.
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sample management jobs in Cambridge, MA
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